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Page 2 of 2 Request for Quote (RFQ) #: 36C25919Q0294 Axumin for PET/CT Imaging of Prostate Tumors This is a combined synopsis/solicitation for commercial items prepared in accordance with the format i... Page 2 of 2 Request for Quote (RFQ) #: 36C25919Q0294 Axumin for PET/CT Imaging of Prostate Tumors This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in FAR Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; quotes are being requested and a written solicitation will not be issued. The Government reserves the right to make no award from this solicitation. **Questions shall be submitted in writing to Matt Zorch at paul.zorch@va.gov no later than 4:00 p.m. EST, May 30, 2019. ** Quotes are to be provided to Matt Zorch at paul.zorch@va.gov no later than 4:00pm EST, June 7, 2019. Quotes shall not be hand carried. Faxed quotes shall not be accepted. Emailed quotes are the only method of submitted quotes (4MB email limit). The Government reserves the right to make award solely on initial Quotes received. Offerors bear the burden of ensuring that all portions of the offer (and any authorized amendments) reach the designated office before the deadline specified in the solicitation. This RFQ shall be completed in its entirety, and signed and dated, failure shall not be considered for award. This is a Request for Quote (RFQ) and the solicitation number is 36C25919Q0294. The government anticipates awarding a firm-fixed price contract resulting from this solicitation. This solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2019-02TA effective May 6, 2019. The North American Industrial Classification System (NAICS) code for this procurement is 325412 with a small business size standard of 1,250 employees. This solicitation is issued on a full and open basis. List of Line Items; Base Year Line Item Description Quantity Unit Unit Price Total Price 0001 Axumin 15 EA 0002 Delivery 15 EA 0003 Case Return/Pick up 15 EA -------------- ----------------- Base Year Total: Option Year 1 Line Item Description Quantity Unit Unit Price Total Price 1001 Axumin 15 EA 1002 Delivery 15 EA 1003 Case Return/Pick up 15 EA -------------- ----------------- Option Year 1 Total: Option Year 2 Line Item Description Quantity Unit Unit Price Total Price 2001 Axumin 15 EA 2002 Delivery 15 EA 2003 Case Return/Pick up 15 EA -------------- ----------------- Option Year 2 Total: Option Year 3 Line Item Description Quantity Unit Unit Price Total Price 3001 Axumin 15 EA 3002 Delivery 15 EA 3003 Case Return/Pick up 15 EA -------------- ----------------- Option Year 3 Total: Option Year 4 Line Item Description Quantity Unit Unit Price Total Price 4001 Axumin 15 EA 4002 Delivery 15 EA 4003 Case Return/Pick up 15 EA -------------- ----------------- Option Year 4 Total: Grand Total (Base and Four Option Years): Description of Requirements for the items to be acquired (salient characteristics); Axumin injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate antigen (PSA) levels following prior treatment. Delivery and acceptance is to be F.O.B Destination (FAR 52.247-34) at the Veterans Affairs Medical Center, located at 921 NE 13th Street Oklahoma City, OK 73104 52.212-1, Instructions to Offerors--Commercial ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS COMMERCIAL Gray market items are Original Equipment Manufacturer s (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts) for VA Medical Centers. No remanufactures or gray market items will be acceptable. Offeror shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed medical supplies, medical equipment and/or services contracts for maintenance of medical equipment (i.e. replacement parts), verified by an authorization letter or other documents from the OEM, such that the OEM s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the medical supplies, medical equipment and/or services contracts for maintenance of medical equipment shall be in accordance with the OEM terms and conditions. The delivery of gray market items to the VA in the fulfillment of an order/award constitutes a breach of contract. Accordingly, the VA reserves the right enforce any of its contractual remedies. This includes termination of the contract or, solely at the VA s election, allowing the Vendor to replace, at no cost to the Government, any remanufactured or gray market item(s) delivered to a VA medical facility upon discovery of such items. Any award made as a result of this solicitation will be made on an All or Nothing Basis. State if quoted items are available and priced through offerors existing Government-wide Acquisition Contract (GWAC), GSA Multiple Award Schedule (MAS) contract, or VA-wide Acquisition Contract. If the acquisition is set-aside for SDVOSBs/VOSBs, their socioeconomic status must be VIP verified and visible in the VA Vendor Information Pages (VIP): https://www.vip.vetbiz.gov/ at the time of quote submission AND award, or will be considered non-responsive, and will NOT be considered for award. Offerors are warned against contacting any VA personnel other than the Contracting Officer and Contract Specialist prior to placement of any award made resulting from this RFQ. If such contact occurs and found to be prejudicial to competing contactors, the offeror making such contact may be excluded from award considerations. All proprietary information shall be clearly and properly marked. If the Offeror submits annexes, documentation, attachments or the like, not specifically required by this solicitation, such will count against the Offeror s page limitations unless otherwise indicated in the specific volume instructions below. All information shall be confined to the appropriate file. The offeror shall confine submissions to essential matters, sufficient to define the quote and provide an adequate basis for evaluation. Offerors are responsible for including sufficient details, in a concise manner, to permit a complete and accurate evaluation of each quote. Submission of quote shall include the following volumes: (I) Price, (II) Narrative to Support the General and Special Standards of Responsibility Volume I Price - The offeror shall complete the pricing schedule provided in Section (v) above: Price/Cost Schedule. Volume II General and Special Standards of Responsibility - To assist the contracting officer in determining if the general and special standards of responsibility applicable to this procurement are met, offerors are asked to provide the following information with their quotes. Failure to include this information could result in a contracting officer s determination that an otherwise successful offeror is not eligible for contract award. General Standards of Responsibility: G1: Offeror shall provide a narrative to demonstrate they are capable of meeting the requirements identified in the Statement of Work. The narrative shall include evidence that the offeror is financially responsible and able to provide past performance evidence of their reliability, ability, experience, equipment, facilities and personnel to provide prompt satisfactory service. The past performance evidence shall include three references for the satisfactory delivery of Axumin to the Government within the last three years. Special Standards of Responsibility: SP1: Special Licensure. Offeror shall provide evidence that personnel performing work under the contract hold a License to prepare and distribute radiopharmaceuticals issued by the United States Nuclear Regulatory Commission (USNRC) or Agreement State. SP2: Special Licensure. Offeror shall employ licensed Nuclear Pharmacists to oversee daily operations. A license for each pharmacist shall be provided. SP3: Regulatory Requirements. Offeror shall meet all USNRC/Agreement State, Department of Transportation, Federal Drug Administration (FDA), Occupational Safety and Health Administration, and Pharmacy/Pharmacist Licensing requirements (Federal and State) as well as any applicable Joint Commission requirements. (End of Addendum to 52.212-1) 52.212-2, Evaluation--Commercial Items ADDENDUM to FAR 52.212-2 EVALUATION COMMERCIAL ITEMS: (a) Basis of Award. This procurement is being conducted pursuant to FAR Part13 procedures. The Government intends to award a contract resulting from this solicitation to the responsible offeror whose quote, conforming to the solicitation, quotes the lowest price, whose quoted price does not exceed the amount of funding available for the procurement, and whose quoted price is found to be reasonable. Price alone is the sole evaluation factor. In addition to the general standards of responsibility found at FAR § 9.104-1, in accordance with FAR § 9.104-2, the special standards of responsibility described below apply to this procurement. Offerors who fail to meet any special standard of responsibility will not be eligible to receive contract award. SP1: Special Licensure. Offeror shall provide evidence that personnel performing work under the contract hold a License to prepare and distribute radiopharmaceuticals issued by the United States Nuclear Regulatory Commission (USNRC) or Agreement State. SP2: Special Licensure. Offeror shall employ licensed Nuclear Pharmacists to oversee daily operations. A license for each pharmacist shall be provided. SP3: Regulatory Requirements. Offeror shall meet all USNRC/Agreement State, Department of Transportation, Federal Drug Administration (FDA), Occupational Safety and Health Administration, and Pharmacy/Pharmacist Licensing requirements (Federal and State) as well as any applicable Joint Commission requirements. (b) Evaluation Process. Quotes will be evaluated in the following manner. The lowest-priced quote] will be identified. The lowest-priced quote will be evaluated to determine if the quoted price exceeds the amount of funding available for the procurement. If the quoted price does not exceed the amount of funding available for the procurement, the quoted price will be evaluated to determine if it is reasonable. If the quoted price is found to be reasonable, the offeror who submitted this quote will be identified as the successful offeror. The contracting officer will then determine if the successful offeror is responsible using the general standards of responsibility and the special standards of responsibility applicable to this procurement. If contract award cannot be made to the successful offeror, the contracting officer will evaluate the next lowest-priced quote following the procedures described above. This process will continue until a contract award can be made, or the contracting officer determines that no contract award can be made. The contracting officer may find all quotes not acceptable and cancel the solicitation if the lowest-priced quote exceeds the amount of funding available for the procurement. The contracting officer may likewise find a quote under evaluation, as well as all remaining quotes, not acceptable and cancel the solicitation if the quote currently under evaluation exceeds the amount of funding available for the procurement. The Government intends to evaluate quotes and award a contract without discussions with offerors. However, the Government reserves the right to conduct discussions at any time if determined by the contracting officer to be in the Government s interest. (c) Options. The Government will evaluate quotes for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that a quote is unacceptable if the option prices are significantly unbalanced or if the quoted price for the basic requirement or any option exceeds the amount of funding available for any of those requirements. Evaluation of options shall not obligate the Government to exercise the option(s). (End of Addendum to 52.212-2) Offerors are advised to include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications Commercial Items, with the offer. 52.212-4, Contract Terms and Conditions--Commercial Items applies to this acquisition 52.212-5, Contract Terms and Conditions Required to Implement Statutes or Executive Orders--Commercial Items FAR 52.212-5 applies to this acquisition with the following FAR clauses incorporated by reference; FAR 52.203-6 Restrictions on Subcontractor Sales to the Government (SEPT 2006), with Alternate I (OCT 1995) (41 U.S.C. 4704 and 10 U.S.C. 2402) FAR 52.204-10 Reporting Executive Compensation & First-Tier Subcontract Awards (OCT 2016) (Pub. L. 109-282) (31 U.S.C. 6101 note) FAR 52.209-6 Protecting the Government s Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (OCT 2015) (31 U.S.C. 6101 note) FAR 52.219-8 Utilization of Small Business Concerns (NOV 2016) (15 U.S.C. 637(d)(2) and (3)); FAR 52.219-28 Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)) FAR 52.222-3 Convict Labor (June 2003) (E.O. 11755) FAR 52.222-19 Child Labor Cooperation with Authorities and Remedies (OCT 2016) (E.O. 13126) FAR 52.222-21 Prohibition of Segregated Facilities (APR 2015) FAR 52.222-26 Equal Opportunity (SEP 2016) (E.O. 11246) FAR 52.222-35 Equal Opportunity for Veterans (OCT 2015) (38 U.S.C. 4212) FAR 52.222-36 Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793) FAR 52.222-37 Employment Reports on Veterans (FEB 2016) (38 U.S.C. 4212) FAR 52.222-40 Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496) FAR 52.222-50 Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627) FAR 52.223-18 Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) FAR 52.225 5 Trade Agreements (OCT 2016) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note) FAR 52.225-13 Restrictions on Certain Foreign Purchases (JUN 2008) (E.O.'s, proclamations, and statutes administered by the Office of Foreign Assets Control of the Department of the Treasury) FAR 52.232-33 Payment by Electronic Funds Transfer System for Award Management (Jul 2013) (31 U.S.C. 3332) Additional contract requirements or terms and conditions: 52.252-2, Clauses Incorporated by Reference (Feb 1998) This contract incorporates one or more clauses 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. Also, the full text of a clause may be accessed electronically at this/these address(es): http://www.acquisition.gov/far/index.html http://www.va.gov/oal/library/vaar/ The following FAR clauses are incorporated by reference: 52.204-7 System for Award Management The following VAAR clauses are to be incorporated by reference: 852.203-70 Commercial Advertising (JAN 2008); 852.232-72 Electronic Submission of Payment Requests (NOV 2012); 852.246-70 Guarantee (JAN 2008); 852.246-71 Inspection (JAN 2008) 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/index.html (FAR) http://www.va.gov/oal/library/vaar/index.asp (VAAR) The following FAR provisions are to be incorporated by reference: FAR 52.211-6 Brand Name or Equal (AUG 1999) The following VAAR provisions are to be incorporated by reference: 852.273-70 Late Offers (JAN 2003); 852.273-72 Alternate Evaluation (JAN 2003); and 852.273-74 Award Without Exchanges (JAN 2003). The Defense Priorities and Allocations System (DPAS) does not apply. Date and Time offers are due to Matt Zorch at paul.zorch@va.gov by 4:00pm EST, June 7, 2019. Name and email of the individual to contact for information regarding the solicitation: Matt Zorch Paul.zorch@va.gov