Inactive Service-Disabled Veteran-Owned Small Business (SDVOSB) Set-Aside (FAR 19.14)

COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information: Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24720Q0143 Posted Date: December 27, 2019 Original Respon... COMBINED SYNOPSIS/SOLICITATION FOR COMMERCIAL ITEMS General Information: Document Type: Combined Solicitation/Synopsis Solicitation Number: 36C24720Q0143 Posted Date: December 27, 2019 Original Response Date: January 13, 2019 Current Response Date: 12:00AM EST Product or Service Code: PRODUCT Set Aside (SDVOSB/VOSB): SDVOSB NAICS Code: 334517 Contracting Office Address: WJB Dorn VA Medical Center 6439 Garners Ferry Road Columbia, SC 29209 Description: This is a 100% Set-Aside SDVOSB combined synopsis/solicitation for commercial items prepared in accordance with the format in Federal Acquisition Regulation (FAR) subpart 12.6, Streamlined Procedures for Evaluation and Solicitation for Commercial Items, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation; Quotations are being requested, and a written solicitation document will not be issued. This solicitation is a request for quotations (RFQ). The associated North American Industrial Classification System (NAICS) code for this procurement is 334517, with a small business size standard of 1250 employees. The Ralph H. Johnson VA Medical Center, located at 109 Bee Street, Charleston, SC 29401 is seeking to purchase an Hologic Securview. Requirement is Brand Name or Equal, see FAR 52.211-6. Prior to submitting a quote: SD/VOSB Vendors shall be Verified in https://www.vip.vetbiz.va.gov/ and All Vendors shall be Registered as Active in https://www.sam.gov/SAM/ Point of Contact: POC for this acquisition is Cedric Belmont, 803-776-4000, Ext: 1836; cedric.belmont@va.gov All interested companies shall provide quotation(s) for the following: Vendor Q&A I copy and pasted the questions below, with answers highlighted. You mentioned they are keeping the existing Securview workstation and will need a quote for the Windows 10 upgrade so that it will match the new one. We are waiting for the Field Engineer that covers the facility to verify the model of the monitors and the computer unless someone onsite can provide that to us in the meantime. Monitors have a model number on the backplate of MDMG/5221; workstations are SecurView DX workstations We will also find out from the Field Engineer if the existing workstation has the Multiview Modality to insure, we make the new quote match. But the big question we had regarding this from our call today is if the Radiologists read both breast ultrasounds and breast MRI s or just breast ultrasounds? If you can clarify that for us that would be great. Existing does have Multiview modality Gabe mentioned to please find out from the site if their current AppSync is working properly with their reporting software? Appsync is working Supplies: Line Item Description Quantity Unit Price Total Price 0001 Securview-DX 400 (STD/CLNT) 1 EA 0002 SVDX License & Accessory Kit - US 1 EA 0003 UPS for SVDX, SVRT, or Managers US 1 EA 0004 Barcode Reader for SVDX, SVRT, or Managers 1 EA 0005 Securview Generic display for APP SYNC or patient list 1 EA 0006 Securview DX Training, Initial, Remote, 1 site, max 5 RADS 1 EA 0007 Third party application synchronization license for WS-SW-1020 1 EA 0008 Securview-DX 600 MGR 1 EA 0009 UPS for SVDX, SVRT, or Managers US 1 EA 0010 Securview DX training, initial, remote, 1 site, Max 5 RADS 1 EA 0011 SVDX manager license & accessory kit -US 1 EA 0012 Multiview multimodality (MM) software and single user license 1 EA 0013 Application synchronization software for Multiview/Securview DX 1 EA 0014 Third party application synchronization license for WS-SW-1020 1 EA 0015 Securview DX/RT workstation upgrade computer (windows 7 64-Bit) w/service contract 1 EA 0016 Securview DX 400, Windows 7 OS upgrade kit, US, service contract 1 EA Delivery shall be provided no later than 30 days after receipt of order/award of contract. Salient Characteristics: Monitor Salient Characteristics: Dual-head monitor that can act as two bezel-free heads or one wide-screen head, or two individual monitor setup that can work in tandem. Monitor must include integrated screen calibration sensor for maintaining DICOM-quality calibrations. Monitor must include calibration software to operate the integrated sensor and give users the capability of delivering calibration reports must be included by the manufacturer at no additional charge or recurring fees beyond initial purchase. A dedicated graphics card and drivers approved for use with the monitor by the manufacturer of the monitor must be included for each monitor purchased. The dedicated graphics card provided with each monitor must have a minimum of 2 DisplayPort outputs. Monitor must be approved for use in both 2D and 3D mammography study reading. Monitor must include ambient light compensation sensor Minimum resolution per head: 5MP / 2048 x 2560 Maximum pixel pitch: 0.18mm or lower Minimum Display depth: 10-bit Maximum luminance: 1800 cd/m2 or greater DICOM-calibrated luminance: 1000 cd/m2 or greater Minimum Contrast Ratio (typical): 900:1 Minimum viewing angle: 170o Primary connection to workstation: DisplayPort 1.1a or newer Certification: FDA 510k for Radiology Workstation Salient Characteristics: Operating System: Windows 10 Professional 64-bit CPU: Intel Xeon 6130 (2.1GHz or greater) or equivalent 64-bit workstation architecture CPU Minimum 16 cores Minimum 2MB L3 cache per core Memory: 16 GB DDR4-2666 or greater Internal storage: 7 TB (or greater) internal storage (RAID 5 setup) Graphics Processor: Dedicated graphics card / integrated graphics processor. 650MHz or greater dedicated GPU 2GB or greater dedicated graphics memory PCIe 3.0 x16 interface Minimum of 2 DisplayPort video outputs Expansion slots: Minimum of 3 PCIe 3.0 x16 slots Media Drive: Minimum of 1 DVD-RW drive Network Interface: Minimum of 1 Gigabit ethernet connection USB and other peripheral connections: Minimum of 2 USB 3.1 ports Minimum of 3 USB 2 ports Additional Workstation Peripherals and Software: Dedicated mammography workflow controller for manipulation of mammography studies Barcode reader Mammography-based image review software compatible with processing images from existing facility-owned Selenia Dimensions 3D mammography acquisition system. Software to provide and process Computer Aided Detection (CAD) and other detection/analysis tools. Place of Performance: Address: Ralph H. Johnson VA Medical Center Postal Code: 29401 Country: UNITED STATES The Government will award to the lowest priced technically acceptable quoter that conforms to all salient characteristics and all requirements identified within the combined synopsis / solicitation. Evaluation Procedures: Addendum to FAR CLAUSE 52.212-1 Instruction to Offerors The Government will award to the lowest priced technically acceptable offeror that conforms to all salient characteristics and all requirements identified within the solicitation. The non-price evaluation factors and sub factors as included in the solicitation are as follows: Factor Sub-factor # Sub-factor Name Sub-Factor Description Technical Capability 1 Authorized reseller All offerors must be an authorized dealer / distributor / reseller / installer of the items quoted to include the purchase, installation, set-up/programming and training. An acceptable approach shall document the offeror is an authorized dealer / distributor / reseller / installer of all items quoted for sale. An acceptable approach shall not include any Gray Market items. Technical Capability 2 Compatibility An acceptable approach must document the following: a. Must meet all salient characteristics identified within the Schedule of Supplies CLAUSES The full text of FAR provisions or clauses may be accessed electronically at http://acquisition.gov/comp/far/index.html. Provision 52.212-1, Instructions to Offerors Commercial (Oct 2015), applies to this acquisition. Addendum to FAR 52.212-1 Instructions to Offerors Commercial Items: All provisions and clauses applicable to this solicitation can be viewed in full text using the following web addresses: http://www.acquisition.gov/far/index.html and http://www.va.gov/oal/library/vaar/ 52.211-6 Brand Name or Equal (AUG 1999) 52.212-3 Offeror Representation and Certification Commercial Items (FEB 2016) with their offer. Provision at 52.212-3 Offeror Representation and Certification can be accessed electronically at the following web address: http://www.acquisition.gov/far/index.html Clause 52.212-4, Contract Terms and Conditions - Commercial Items, applies to this acquisition. Clause 52.212-5 Contract Terms and Conditions Required to Implement Statues or Executive Orders Commercial Items (APR 2015) applies to this acquisition. (a) The Contractor shall comply with the following Federal Acquisition Regulation (FAR) clauses, which are incorporated in this contract by reference, to implement provisions of law or Executive orders applicable to acquisitions of commercial items: (1) 52.209-10, Prohibition on Contracting with Inverted Domestic Corporations (Dec 2014) (2) 52.233-3, Protest After Award (Aug 1996) (31 U.S.C. 3553). (3) 52.233-4, Applicable Law for Breach of Contract Claim (Oct 2004) (Public Laws 108-77 and 108-78 (19 U.S.C. 3805 note). (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: [] (1) 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). [] (2) 52.203-13, Contractor Code of Business Ethics and Conduct (APR 2010) (41 U.S.C. 3509). (3) 52.203-15, Whistleblower Protections under the American Recovery and Reinvestment Act of 2009 (JUN 2010) (Section 1553 of Pub. L. 111-5). (Applies to contracts funded by the American Recovery and Reinvestment Act of 2009.) [x] (4) 52.204-10, Reporting Executive Compensation and First-Tier Subcontract Awards (Jul 2013) (Pub. L. 109-282) (31 U.S.C. 6101 note). [] (5) [Reserved] [] (6) 52.204-14, Service Contract Reporting Requirements (JAN 2014) (Pub. L. 111- 117, section 743 of Div. C). [] (7) 52.204-15, Service Contract Reporting Requirements for Indefinite-Delivery Contracts (JAN 2014) (Pub. L. 111-117, section 743 of Div. C). [X] (8) 52.209-6, Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment. (Aug 2013) (31 U.S.C. 6101 note). [] (9) 52.209-9, Updates of Publicly Available Information Regarding Responsibility Matters (Jul 2013) (41 U.S.C. 2313). [] (10) [Reserved] [] (11)(i) 52.219-3, Notice of HUBZone Set-Aside or Sole-Source Award (NOV 2011) (15 U.S.C. 657a). [] (ii) Alternate I (NOV 2011) of 52.219-3. [] (12)(i) 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). [] (ii) Alternate I (JAN 2011) of 52.219-4. [] (13) [Reserved] [x] (14)(i) 52.219-6, Notice of Total Small Business Set-Aside (NOV 2011) (15 U.S.C. 644). [] (ii) Alternate I (NOV 2011). [] (iii) Alternate II (NOV 2011). [] (15)(i) 52.219-7, Notice of Partial Small Business Set-Aside (June 2003) (15 U.S.C. 644). [] (ii) Alternate I (Oct 1995) of 52.219-7. [] (iii) Alternate II (Mar 2004) of 52.219-7. [] (16) 52.219-8, Utilization of Small Business Concerns (OCT 2014) (15 U.S.C. 637(d)(2) and (3). [] (17)(i) 52.219-9, Small Business Subcontracting Plan (OCT 2014) (15 U.S.C. 637(d)(4)). [] (ii) Alternate I (Oct 2001) of 52.219-9. [] (iii) Alternate II (Oct 2001) of 52.219-9. [] (iv) Alternate III (OCT 2014) of 52.219-9. [] (18) 52.219-13, Notice of Set-Aside of Orders (NOV 2011) (15 U.S.C. 644(r)). [] (19) 52.219-14, Limitations on Subcontracting (NOV 2011) (15 U.S.C. 637(a)(14)). [] (20) 52.219-16, Liquidated Damages Subcontracting Plan (Jan 1999) (15 U.S.C. 637(d)(4)(F)(i)). [X] (21) 52.219-27, Notice of Service-Disabled Veteran-Owned Small Business Set-Aside (NOV 2011) (15 U.S.C. 657f). [] (22) 52.219-28, Post Award Small Business Program Representation (Jul 2013) (15 U.S.C 632(a)(2)). [] (23) 52.219-29, Notice of Set-Aside for Economically Disadvantaged Women-Owned Small Business (EDWOSB) Concerns (Jul 2013) (15 U.S.C. 637(m)). [] (24) 52.219-30, Notice of Set-Aside for Women-Owned Small Business (WOSB) Concerns Eligible Under the WOSB Program (Jul 2013) (15 U.S.C. 637(m)). [X] (25) 52.222-3, Convict Labor (June 2003) (E.O. 11755). [X] (26) 52.222-19, Child Labor Cooperation with Authorities and Remedies (JAN 2014) (E.O. 13126). [X] (27) 52.222-21, Prohibition of Segregated Facilities (APR 2015). [X] (28) 52.222-26, Equal Opportunity (APR 2015) (E.O. 11246). [] (29) 52.222-35, Equal Opportunity for Veterans (JUL 2014) (38 U.S.C. 4212). [X] (30) 52.222-36, Equal Opportunity for Workers with Disabilities (JUL 2014) (29 U.S.C. 793). [] (31) 52.222-37, Employment Reports on Veterans (JUL 2014) (38 U.S.C. 4212). [] (32) 52.222-40, Notification of Employee Rights Under the National Labor Relations Act (DEC 2010) (E.O. 13496). [X] (33)(i) 52.222-50, Combating Trafficking in Persons (MAR 2015) (22 U.S.C. chapter 78 and E.O. 13627). [] (ii) Alternate I (MAR 2015) of 52.222-50 (22 U.S.C. chapter 78 and E.O. 13627). [] (34) 52.222-54, Employment Eligibility Verification (AUG 2013). (Executive Order 12989). (Not applicable to the acquisition of commercially available off-the-shelf items or certain other types of commercial items as prescribed in 22.1803.) [] (35)(i) 52.223-9, Estimate of Percentage of Recovered Material Content for EPA-Designated Items (May 2008) (42 U.S.C.6962(c)(3)(A)(ii)). (Not applicable to the acquisition of commercially available off-the-shelf items.) [] (ii) Alternate I (MAY 2008) of 52.223-9 (42 U.S.C. 6962(i)(2)(C)). (Not applicable to the acquisition of commercially available off-the-shelf items.) [X] (36)(i) 52.223-13, Acquisition of EPEAT®-Registered Imaging Equipment (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-13. [] (37)(i) 52.223-14, Acquisition of EPEAT®-Registered Televisions (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-14. [] (38) 52.223-15, Energy Efficiency in Energy-Consuming Products (DEC 2007)(42 U.S.C. 8259b). [] (39)(i) 52.223-16, Acquisition of EPEAT®-Registered Personal Computer Products (JUN 2014) (E.O.s 13423 and 13514). [] (ii) Alternate I (JUN 2014) of 52.223-16. [X] (40) 52.223-18, Encouraging Contractor Policies to Ban Text Messaging While Driving (AUG 2011) [X] (41) 52.225-1, Buy American Supplies (MAY 2014) (41 U.S.C. chapter 83). [] (42)(i) 52.225-3, Buy American Free Trade Agreements Israeli Trade Act (MAY 2014) (41 U.S.C. chapter 83, 19 U.S.C. 3301 note, 19 U.S.C. 2112 note, 19 U.S.C. 3805 note, 19 U.S.C. 4001 note, Pub. L. 103-182, 108-77, 108-78, 108-286, 108-302, 109-53, 109-169, 109-283, 110-138, 112-41, 112-42, and 112-43. [] (ii) Alternate I (MAY 2014) of 52.225-3. [] (iii) Alternate II (MAY 2014) of 52.225-3. [] (iv) Alternate III (MAY 2014) of 52.225-3. [] (43) 52.225-5, Trade Agreements (NOV 2013) (19 U.S.C. 2501, et seq., 19 U.S.C. 3301 note). [X] (44) 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). [] (45) 52.225-26, Contractors Performing Private Security Functions Outside the United States (Jul 2013) (Section 862, as amended, of the National Defense Authorization Act for Fiscal Year 2008; 10 U.S.C. 2302 Note). [] (46) 52.226-4, Notice of Disaster or Emergency Area Set-Aside (Nov 2007) (42 U.S.C. 5150). [] (47) 52.226-5, Restrictions on Subcontracting Outside Disaster or Emergency Area (Nov 2007) (42 U.S.C. 5150). [] (48) 52.232-29, Terms for Financing of Purchases of Commercial Items (Feb 2002) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). [] (49) 52.232-30, Installment Payments for Commercial Items (Oct 1995) (41 U.S.C. 4505, 10 U.S.C. 2307(f)). [X] (50) 52.232-33, Payment by Electronic Funds Transfer System for Award Management (Jul 2013) (31 U.S.C. 3332). [X] (51) 52.232-34, Payment by Electronic Funds Transfer Other than System for Award Management (Jul 2013) (31 U.S.C. 3332). [] (52) 52.232-36, Payment by Third Party (MAY 2014) (31 U.S.C. 3332). [] (53) 52.239-1, Privacy or Security Safeguards (Aug 1996) (5 U.S.C. 552a). [] (54)(i) 52.247-64, Preference for Privately Owned U.S.-Flag Commercial Vessels (Feb 2006) (46 U.S.C. Appx. 1241(b) and 10 U.S.C. 2631). [] (ii) Alternate I (Apr 2003) of 52.247-64. (c) The Contractor shall comply with the FAR clauses in this paragraph (c), applicable to commercial services, 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: [] (1) 52.222-17, Nondisplacement of Qualified Workers (MAY 2014) (E.O. 13495). [] (2) 52.222-41, Service Contract Labor Standards (MAY 2014) (41 U.S.C. chapter 67). [] (3) 52.222-42, Statement of Equivalent Rates for Federal Hires (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). [] (4) 52.222-43, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (Multiple Year and Option Contracts) (MAY 2014) (29 U.S.C. 206 and 41 U.S.C. chapter 67). [] (5) 52.222-44, Fair Labor Standards Act and Service Contract Labor Standards Price Adjustment (MAY 2014) (29 U.S.C 206 and 41 U.S.C. chapter 67). [] (6) 52.222-51, Exemption from Application of the Service Contract Labor Standards to Contracts for Maintenance, Calibration, or Repair of Certain Equipment Requirements (MAY 2014) (41 U.S.C. chapter 67). [] (7) 52.222-53, Exemption from Application of the Service Contract Labor Standards to Contracts for Certain Services Requirements (MAY 2014) (41 U.S.C. chapter 67). [] (8) 52.222-55, Minimum Wages Under Executive Order 13658 (DEC 2014) (Executive Order 13658). [] (9) 52.226-6, Promoting Excess Food Donation to Nonprofit Organizations (MAY 2014) (42 U.S.C. 1792). [] (10) 52.237-11, Accepting and Dispensing of $1 Coin (SEP 2008) (31 U.S.C. 5112(p)(1)). (End of Clause) Statement regarding any Additional Provisions and Clauses, or other terms and conditions important to the requirement/procurement process consistent with commercial practices: Provisions in full text: 52.225-18 Place of Manufacture (MAR 2015). (a) Definitions. As used in this clause Manufactured end product means any product in product and service codes (PSCs) 1000-9999, except (1) FPSC 5510, Lumber and Related Basic Wood Materials; (2) Product or Service Group (PSG) 87, Agricultural Supplies; (3) PSG 88, Live Animals; (4) PSG 89, Subsistence; (5) PSC 9410, Crude Grades of Plant Materials; (6) PSC 9430, Miscellaneous Crude Animal Products, Inedible; (7) PSC 9440, Miscellaneous Crude Agricultural and Forestry Products; (8) PSC 9610, Ores; (9) PSC 9620, Minerals, Natural and Synthetic; and (10) PSC 9630, Additive Metal Materials. Place of manufacture means the place where an end product is assembled out of components, or otherwise made or processed from raw materials into the finished product that is to be provided to the Government. If a product is disassembled and reassembled, the place of reassembly is not the place of manufacture. (b) For statistical purposes only, the offeror shall indicate whether the place of manufacture of the end products it expects to provide in response to this solicitation is predominantly (1) [] In the United States (Check this box if the total anticipated price of offered end products manufactured in the United States exceeds the total anticipated price of offered end products manufactured outside the United States); or (2) [] Outside the United States. (End of provision) 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 http://www.va.gov/oal/library/vaar/ (End of provision) 852.252-70 Solicitation provisions or clauses incorporated by reference (JAN 2008). The following provisions or clauses incorporated by reference in this solicitation must be completed by the offeror or prospective contractor and submitted with the quotation or offer. Copies of these provisions or clauses are available on the Internet at the web sites provided in the provision at FAR 52.252-1, Solicitation Provisions Incorporated by Reference, or the clause at FAR 52.252-2, Clauses Incorporated by Reference. Copies may also be obtained from the contracting officer. (End of provision) Provisions incorporated by reference are: - 52.203-11 Certification and Disclosure regarding payments to Influence Certain Federal Transactions (SEP 2007); - 52.204-7 System for Award Management (JUL 2013) - 52.204-17 Ownership or Control of Offeror (NOV 2014) - 52.211-6 Brand Name or Equal (AUG 1999) - 52.212-1 Instructions to Offerors Commercial Items (APR 2014); - 52.225-25 Prohibition on Contracting with entities engaging in certain activities or transactions relating to Iran Representation and Certification (DEC 2012) Clauses in Full Text: 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/ (End of clause) Clauses Incorporated by Reference: - 52.204-13 System for Award Management Maintenance (JUL 2013) - 52.204-18 Commercial and Government Entity Code Maintenance (JUL 2015) - 52.222-20 Contracts for materials, supplies, articles, and equipment exceeding - - $15,000.00 (MAY 2014); - 52.232-1 Payments (APR 1984); - 52.232-8 Discounts for prompt payment (FEB 2002); - 52.243-1 Changes Fixed Price (AUG 1987); - 852.203-70 Commercial Advertising (JAN 2008); - 852.211-73 Brand Name or Equal (JAN 08); - 852.246-70 Guarantee (JAN 2008); - 852.246-71 Inspection (JAN 2008) Provision 52.212-2, Evaluation Commercial Items (OCT 2014), applies to this acquisition. (a) The Government will award a contract resulting from this solicitation to the responsible offeror whose offer conforming to the solicitation will be most advantageous to the Government, price and other factors considered. The following factors will be used to evaluate offers: Price and technical acceptability. A best value award will be made utilizing the lowest price technically acceptable. (b) Additional Instructions to offerors concerning Grey Market items- The VHA (Veterans Health Administration) will not accept Grey Market Goods . Grey market goods are defined as: Gray Market Goods also known as parallel market, is the trade of a commodity through distribution channels which, while legal, are unofficial, unauthorized, or unintended by the original manufacturer. Products that are purchased outside of our authorized distributor network on the gray market generate a number of concerns such as: counterfeit or adulterated devices, inadequate storage conditions, tracking issues in case of a recall, loss of warrantee, and most importantly patient safety. In some instances, unauthorized distributors procure products from an authorized distributor for resale. (c) A written notice of award or acceptance of an offer, mailed or otherwise furnished to the successful offeror within the time for acceptance specified in the offer, shall result in a binding contract without further action by either party. Before the offer s specified expiration time, the Government may accept an offer (or part of an offer), whether or not there are negotiations after its receipt, unless a written notice of withdrawal is received before award.