FBODaily.com | FedBizOpps: PRESOL | 99 | Production and Biosafety Testing of cGMP (current Good Manufacturing Practices) - compliant Transient Gammaretroviral Vector for NCI Clinical Trials.

FBO DAILY - FEDBIZOPPS ISSUE OF JULY 20, 2018 FBO #6083
SOLICITATION NOTICE

99 -- Production and Biosafety Testing of cGMP (current Good Manufacturing Practices) - compliant Transient Gammaretroviral Vector for NCI Clinical Trials.

Notice Date: 7/18/2018
Notice Type: Combined Synopsis/Solicitation
NAICS: 621511 — Medical Laboratories
Contracting Office: Department of Health and Human Services, National Institutes of Health, National Cancer Institute, Office of Acquisitions, 9609 Medical Center Drive, Room 1E128, Rockville, Maryland, 20852, United States
ZIP Code: 20852
Solicitation Number: N02CO82606-95
Archive Date: 8/16/2018
Point of Contact: Ricky J. Watson, Phone: 2402766594
E-Mail Address: ricky.watson@nih.gov
(ricky.watson@nih.gov)
Small Business Set-Aside: N/A
Description: The Department of Health and Human Services (HHS), National institutes of Health (NIH), National Cancer Institute (NCI), Experimental Transplantation and Immunology Branch (ETIB) requires the manufacture of a transient GMP-compliant Gammaretroviral Vector encoding a T cell receptor targeting the KK-LC-1 antigen and conduct biosafety testing on it. The manufactured Retroviral Vector will be used for ETIB/NCI Clinical trials. This is a combined synopsis/solicitation for a commercial item, 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, # N02CO82606-95 is issued as a request for quote (RFQ), and includes all applicable provisions and clauses in effect through FAR Federal Acquisition Circular (FAC) 2005-95 / 01-19-2017, simplified procedures for commercial items. The North American Industry Classification System code is 621511 and the business size standard is $32.5M. Only one award will be made as a result of this solicitation. This will be awarded as a firm fixed price type purchase order. DESCRIPTION OF CONTRACTOR REQUIREMENTS ETIB will provide the initial plasmid along with the vector map. The Contractor will produce a pilot-scale research grade vector and confirm its suitability. The contractor will then sequence, amplify and certify the provided plasmid for GMP use. Upon approval, the plasmid will be used, along with an existing suitable cell line, for the production of 10L transient gammaretroviral vector. The product shall be harvested, filtered, frozen and maintained at < -70o C in aliquots (50 grams/unit). Aliquots of the produced supernatant may be supplied to ETIB/NCI for research and development and evaluation purposes. The Contractor shall be responsible for conducting assay analysis to certify the supernatant based on current FDA guidelines. Certification of the supernatant shall include the tests listed below subject to review of current FDA requirements: • Sterility, Aerobic and anaerobic culture for bacterial and fungal contamination that fully meets or exceeds 21 CFR 610.12 Sterility guidelines • Mycoplasma, including broth, agar, and cell culture that meet the recommended procedure for mycoplasma testing according to the Points to Consider in the Characterization of Cell Lines Used to Produce Biologicals, Attachment #2 (1993). • Detection and Quantitation of residual plasmid DNA Quantitative Polymerase Chain reaction - QPCR) • Detection of Human DNA. • In-Vitro Adventitious Virus Assay. • Safety testing for replication-competent retrovirus (GAL-V RCR). • Endotoxin. • Vector insert stability. • Lyme disease testing (Transfer of E1A). • Testing for Simian virus (Transfer of SV40). • Infectious titer of Vector. The Contractor shall provide 3-year Vector stability testing following the production of the GMP Master Cell bank. NON-CONFORMING VECTOR In the case that the manufactured gammaretroviral vector is found non-conforming within 30 days of delivery of a certificate of analysis, the Contractor will investigate the alleged non-conformity upon request of NCI / ETIB. If the non-conforming product is a result of the Contractor's negligence, the Contractor will opt to either replace the gammaretroviral vector within 240 days from the date that the vector is determined to be non-conforming or refund the purchase price of the non-conforming vector. In the case of dispute regarding the non-conformity of the vector, samples of the vector will be submitted to a mutually agreed third party lab or consultant for evaluation. TYPE OF ORDER This is a firm fixed price purchase order. NON-SEVERABLE SERVICES The services specified in each contract line item (CLIN) have been determined to be non-severable services - a specific undertaking or entire job with a defined end product of value to the Government. PERIOD OF PERFORMANCE The period of performance shall be in accordance with the table below: Manufacture and Certification of Transient Gammaretroviral Vector 8 months from the culture initiation Vector Stability Testing - Year 1 1 year from the manufacture completion Vector Stability Testing - Year 2 1 year from the end of year 1 Vector Stability Testing - Year 3 1 year from the end of year 2 PLACE OF PERFORMANCE The service shall be conducted at the Contractor's facility. REPORT(S)/DELIVERABLES AND DELIVERY SCHEDULE The Contractor shall provide a written monthly progress report to the NCI technical point of contact on the status of individual projects or assays. Upon completion of the manufacturing process and the safety assays, the contractor shall issue and provide a Certificate of Analysis (CoA) and the Gammaretroviral Vector will be released for distribution. As directed by ETIB/NCI and within 8 months of release for distribution, the vector shall be distributed to ETIB/NCI. The deliverables will be 50-100mL sized cassettes (size to be determined between ETIB/NCI and contractor) of frozen gammaretroviral vector along with a detailed Certificate of Analysis. MILESTONES Milestones are determined per the table below: Milestone Number Description 1 Pilot Scale supernatant to be tested for suitability 2 Manufacture of GMP-grade Gammaretroviral Vector 3 Release of Final Product / Issuance of Certificate of Analysis PAYMENT Payment authorization requires submission and approval of invoices to the COR and NIH OFM, in accordance with the payment provisions listed below: Payment Provisions Percentage Milestone 1 TBD at Award Milestone 2 TBD at Award Milestone 3 TBD at Award Year 1 Stability testing* TBD at Award Year 2 Stability testing TBD at Award Year 3 Stability testing TBD at Award *Stability testing begins one year after the completion of the manufacturing and the successful release of the product (Milestone 3). The following clause is applicable to all Purchase Orders, Task or Delivery Orders, and Blanket Purchase Agreement (BPA) Calls: PROMPT PAYMENT (JUL 2013) FAR 52.232-25. Highlights of this clause and NIH implementation requirements follow: I INVOICE REQUIREMENTS A. An invoice is the Contractor's bill or written request for payment under the contract for supplies delivered or services performed. A proper invoice is an "Original" which must include the items listed in subdivisions 1 through 12, below, in addition to the requirements of FAR 32.9. If the invoice does not comply with these requirements, the Contractor will be notified of the defect within 7 days after the date the designated billing office received the invoice (3 days for meat, meat food products, or fish, and 5 days for perishable agricultural commodities, dairy products, edible fats or oils) with a statement of the reasons why it is not a proper invoice. (See exceptions under II., below.) Untimely notification will be taken into account in the computation of any interest penalty owed the Contractor. 1. Vendor/Contractor: Name, Address, Point of Contact for the invoice (Name, title, telephone number, e-mail and mailing address of point of contact). 2. Remit-to address (Name and complete mailing address to send payment). 3. Remittance name must match exactly with name on original order/contract. If the Remittance name differs from the Legal Business Name, then both names must appear on the invoice. 4. Invoice date. 5. Unique invoice #s for all invoices per vendor regardless of site. 6. NBS document number formats must be included for awards created in the NBS: Contract Number; Purchase Order Number; Task or Delivery Order Number and Source Award Number (e.g., Indefinite Delivery Contract number; General Services Administration number); or, BPA Call Number and BPA Parent Award Number. 7. Data Universal Numbering System (DUNS) or DUNS + 4 as registered in the Central Contractor Registration (CCR). 8. Federal Taxpayer Identification Number (TIN). In those exceptional cases where a contractor does not have a DUNS number or TIN, a Vendor Identification Number (VIN) must be referenced on the invoice. The VIN is the number that appears after the contractor's name on the face page of the award document. 9. Identify that payment is to be made using a three-way match. 10. Description of supplies/services that match the description on the award, by line billed.* 11. Freight or delivery charge must be billed as shown on the award. If it is included in the item price do not bill it separately. If identified in the award as a separate line item, it must be billed separately. 12. Quantity, Unit of Measure, Unit Price, Extended Price of supplies delivered or services performed, as applicable, and that match the line items specified in the award.* * NOTE: If your invoice must differ from the line items on the award, please contact the Contracting Officer before submitting the invoice. A modification to the order or contract may be needed before the invoice can be submitted and paid. B. Shipping costs will be reimbursed only if authorized by the Contract/Purchase Order. If authorized, shipping costs must be itemized. Where shipping costs exceed $100, the invoice must be supported by a bill of lading or a paid carrier's receipt. C. Mail an original and 1 copy of the itemized invoice to: National Institutes of Health Office of Financial Management, Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500 For inquiries regarding payment call: (301) 496-6088 In order to facilitate the prompt payment of invoices, it is recommended that the vendor submit a photocopy of the invoice to the "Consignee" designated for the acquisition in blocks 6A - 6E of the face page of the Order/Award document. II. INVOICE PAYMENT A. Except as indicated in paragraph B., below, the due date for making invoice payments by the designated payment office shall be the later of the following two events: 1. The 30th day after the designated billing office has received a proper invoice. 2. The 30th day after Government acceptance of supplies delivered or services performed. B. The due date for making invoice payments for meat and meat food products, perishable agricultural commodities, dairy products, and edible fats or oils, shall be in accordance with the Prompt Payment Act, as amended. III. INTEREST PENALTIES A. An interest penalty shall be paid automatically, if payment is not made by the due date and the conditions listed below are met, if applicable. 1. A proper invoice was received by the designated billing office. 2. A receiving report or other Government documentation authorizing payment was processed and there was no disagreement over quantity, quality, or contractor compliance with a term or condition. 3. In the case of a final invoice for any balance of funds due the contractor for supplies delivered or services performed, the amount was not subject to further settlement actions between the Government and the Contractor. B. Determination of interest and penalties due will be made in accordance with the provisions of the Prompt Payment Act, as amended, the Contract Disputes Act, and regulations issued by the Office of Management and Budget. IV. PROVIDING ACCELERATED PAYMENT TO SMALL BUSINESS SUBCONTRACTORS, FAR 52.232-40 (DEC 2013) a) Upon receipt of accelerated payments from the Government, the Contractor shall make accelerated payments to its small business subcontractors under this contract, to the maximum extent practicable and prior to when such payment is otherwise required under the applicable contract or subcontract, after receipt of a proper invoice and all other required documentation from the small business subcontractor. b) The acceleration of payments under this clause does not provide any new rights under the prompt Payment Act. Include the substance of this clause, include this paragraph c, in all subcontracts with small business concerns, including subcontracts with small business concerns for the acquisition of commercial items. DELIVERY POINT: All information furnished must be in writing and must contain sufficient detail to allow the NCI to determine if it can meet the unique specifications described herein. All questions must be in writing and should be emailed to Ricky Watson, Contract Specialist at ricky.watson@nih.gov. A determination by the Government not to compete this requirement based upon responses to this notice is solely within the discretion of the Government. Information received will be considered solely for the purpose of determining whether to conduct a competitive procurement. In order to receive an award, contractors must have valid registration and certification in the System for Awards Management (SAM) at www.sam.gov. No collect calls will be accepted. Please reference number N02CO82606-95 on all correspondence. Disclaimer and Important Notes: This notice does not obligate the Government to award a contract or otherwise pay for the information provided in response. The Government reserves the right to use information provided by respondents for any purpose deemed necessary and legally appropriate. Any organization responding to this notice should ensure that its response is complete and sufficiently detailed to allow the Government to determine the organization's qualifications to perform the work. Respondents are advised that the Government is under no obligation to acknowledge receipt of the information received or provide feedback to respondents with respect to any information submitted. After a review of the responses received, an RFQ may be published. However, responses to this notice will not be considered adequate responses to a solicitation(s). POINT OF CONTACT: Inquiries concerning this Notice may be direct to: Ricky Watson 9609 Medical Center Dr. Bethesda, MD 20892-9705 Ricky.watson@nih.gov CLAUSES AND PROVISIONS The following FAR provisions and clauses apply to this acquisition: 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 Ricky Watson, Contract Specialist at ricky.watson@nih.gov. FAR 52.212-1 INSTRUCTION TO OFFERORS COMMERCIAL ITEMS (JAN 2017) FAR 52.212-2 EVALUATION COMMERCIAL ITEMS (OCT 2014) FAR 52.212-3 OFFERORS REPRESENTATIONS AND CERTIFICATIONS -COMMERCIAL ITEMS (JAN 2017) FAR 52.212-4 CONTRACT TERMS AND CONDITIONS - COMMERCIAL ITEMS (JAN 2017) 52.222-22 PREVIOUS CONTRACTS AND COMPLIANCE REPORTS. Previous Contracts and Compliance Reports (Feb 1999) The offeror represents that -- (a) It has, has not participated in a previous contract or subcontract subject to the Equal Opportunity clause of this solicitation; (b) It has, has not filed all required compliance reports; and (c) Representations indicating submission of required compliance reports, signed by proposed subcontractors, will be obtained before subcontract awards. 52.222-25 -AFFIRMATIVE ACTION COMPLIANCE. Affirmative Action Compliance (Apr 1984) The offeror represents that -- (a) It has developed and has on file, has not developed and does not have on file, at each establishment, affirmative action programs required by the rules and regulations of the Secretary of Labor (41 CFR 60-1 and 60-2); or (b) It has not previously had contracts subject to the written affirmative action programs requirement of the rules and regulations of the Secretary of Labor. 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 (MAR 2016). 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). 52.204-10 Reporting Executive Compensation and First Tier Subcontract Awards (OCT 2015) (Pub.L. 109-282) (31 U.S.C. 6101 note). 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). 52.219-1 Small Business Program Representations 52.219-4 Notice of Price Evaluation Preference for HUBZone Small Business Concerns (Jan 2011) (if the offeror elects to waive the preference, it shall so indicate in its offer) (15 U.S.C. 657a). 52.219-8 Utilization of Small Business Concerns (Jan 2011) (15 U.S.C. 637(d)(2) and (3)). 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). 52.222-21 Prohibition of Segregated Facilities (APR 2015) 52.222-26 Equal Opportunity (APR 2015) (E.O. 11246). 52.222-35 Equal Opportunity for Veterans (Sep 2010) (38 U.S.C. 4212). 52.222-37 Employment Reports on Veterans (Sep 2010) (38 U.S.C. 4212). 52.222-36 Affirmative Action for Workers with Disabilities (Oct 2010) (29 U.S.C. 793). 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (Dec 2010) (E.O. 13496). 52.222-50 Combating Trafficking in Persons 52.222-54 Employment Eligibility Verification (Jan 2009). (Executive Order 12989). 52.223-18 Encouraging Contractor Policies to Ban Text Messaging while Driving (AUG 2011) (E.O. 13513). 52.225-3 Buy American Act -Free Trade Agreements - Israeli Trade Act (Jun 2009) (41 U.S.C. 10a-10d, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, Pub. L. 108-77, 108-78, 108-286, 108-301, 109-53, 109-169, 109-283, and 110-138). 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 (JUL 2013) (31 U.S.C. 3332). SUBMISSION INFORMATION Questions must be submitted electronically (via email) to Contract Specialist, Ricky Watson, at ricky.watson@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 11:00 AM EST on Wednesday, July 25, 2018. Quotations must be submitted electronically (via email) to Contract Specialist, Ricky Watson, at ricky.watson@nih.gov in MS Word or Adobe Portable Document Format (PDF), no later than 11:00 AM EST, on Wednesday, August 1, 2018. All responses must be received by the specified due date and time in order to be considered. QUOTATIONS RECEIVED AFTER THIS DATE AND TIME WILL NOT BE CONSIDERED. No collect calls will be accepted. Please refer to solicitation no: N02CO82606-95 on all correspondence. Evaluation Award will be made to the responsible firm submitting the lowest priced technically acceptable (LPTA) offer; and meeting or exceeding the acceptability standards for the requirements / technical specifications stated above. A technically acceptable quotation is one in which the Quoter complies with the requirements/technical specifications stated above, and does not take exception, nor object to any of the terms contained in this request. Quotations 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 quotations if such action is in the public interest; accept other than the lowest quotation; and waive informalities and minor irregularities in quotations received. NOTE: Quoters must submit information sufficient to evaluate their quotations based on the detailed factors listed below. Price Quotation The Quoter shall prepare a price quotation that contains all information necessary to allow for a comprehensive evaluation of the prices quoted. Specifically, your quote must include the following: Federal Tax Identification Number (TIN); Data Universal Numbering System (DUNS) Number; and Business Size (e.g., small or large).
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99 -- Production and Biosafety Testing of cGMP (current Good Manufacturing Practices) - compliant Transient Gammaretroviral Vector for NCI Clinical Trials.