Intent to Sole Source MACI Implant sheets

Notice of Intent to Sole Source THIS IS A NOTICE OF INTENT TO AWARD A SOLE SOURCE CONTRACT AND IS NOT A REQUEST FOR COMPETITIVE QUOTES. Reference#: N0025922N0010. Naval Medical Center San Diego (NMCSD) intends to award a firm fixed price contract under the authority of FAR 13.106-1(b)(1)(i), only one source being available to meet the Government's needs, to: Vericel Corporation 64 Sidney ST Cambridge, Massachusetts 02139-4170, United States The North American Industry Classification System (NAICS) code for this requirement is 339113; the business size standard is 750 (# of employees). The objective of this sole source award is to procure the Matrix-Induced Autologous Chondrocyte Implantation (MACI) for patient scheduled for surgery 03-January-2022. Per patient's anatomy, the MACI must: 1 - Deliver a controlled, uniform dose of cells with a density of 500,000 to 1,000,000 per cm. 2 - Have porous side that facilitates cell attachment and the smooth side aids in joint articulation and 3 - Permit the use of suture anchor fixation when needed. Materials required 31-December-2021 for sterilization prior to surgery. Vericel Corporation is the only source that can supply these items due to the proprietary nature of this item, no other company was found as authorized third-party vendors. This notice of intent is not a request for competitive proposals and no solicitation document exists for the requirement. Sources interested in responding to this notice are required to submit a capability statement that includes management and technical data and cost information, in sufficient detail and with convincing evidence that clearly demonstrates the capability to perform the required work and are able to provide certification validated by Vericel Corporation. Capability statements shall not exceed 6 (8.5 x 11 inch) pages using a font size no smaller than 10-point. All capability statements received by the due date of this notice will be considered by the Government. A request for documentation or additional information or submissions that only ask questions will not be considered as an affirmative response. A determination by the Government not to compete based on 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 or to proceed with a sole source purchase order. Capability statements are due by 07.00 am Pacific Standard Time, 16-December-2021. Capability statements shall be submitted by e-mail ONLY as a Microsoft Word or Adobe PDF attachment to the following address: raphael.k.badagbor.civ@mail.mil . The email subject line shall state, - Naval Medical Center San Diego, Special Notice Number N0025922N0010. NO TELEPHONE REQUESTS/OFFERS WILL BE HONORED