FDA-SOL-FY22-1251866.pdf

FDA-SOL-FY22-1251866

XDR-50 Single Use Bioreactor or Equivalent with Accessories with Training, Installation and Four (4) one (1) Year Optional Maintenance Agreement

This is a combined synopsis/solicitation for commercial services prepared in accordance with the format in FAR 12.6 as supplemented with FAR Part 13 and additional information included in this notice. The incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2022- 05 dated 03/07/2022.

THIS ANNOUNCEMENT CONSTITUTES THE ONLY SOLICITATION AND A SEPARATE SOLICITATION WILL NOT BE ISSUED. The solicitation number for this acquisition is FDA-SOL-FY22-1251866 and is being issued as a Request for Quote (RFQ). The NAICS Code for this solicitation is 334516 - Analytical Laboratory Instrument Manufacturing . This will be awarded as Firm-Fixed Price. The Government reserves the right to award an order without discussions if the Contracting Officer determines that the initial offer is providing the Best Value and discussions are not necessary.

This Solicitation is Full and Open Competition. The Government intends to issue a Purchase Order.

The U. S. Food and Drug Administration (FDA) has a need to procure a XDR-50 use Bioreactor or Equivalent with Accessories with Installation and four (4) one (1) year Optional Maintenance Agreement.

Background:

The FDA Center for Drug Evaluation and Research, Division of Procduct Quality Research (DPQR) conducts proactive research and evaluation to assess the quality attributes of both small molecule drugs and biologics. DPQR is in collaboration with OBP is trying to establish an integrated upstream and downstream production process for manufacturing large molecules such as therapeutic proteins and monoclonal antibodies. A XDR-50 single use bioreactor system or equivalent with accessories usable for fed-batch campaigns and extended production campaigns with perfusion cell culture is required for upstream production process. A bioreactor operable in the range of 20-40 liters capacity is sought for this purpose.

Minimum Required Salient Characteristics:

XDR-50 single use bioreactor system operable in the range of 20-40 liters cell culture volume with a control system and facility for extended perfusion culture operations shall meet the following salient characteristics:

1) Shall operate a single use polymer construct bags with the cell culture volume ranges of 20-40 liters.

2) The single use polymer construct bag and the bioreactor control system shall accommodate process control via agitation, sparging for aeration, pH control, dissolved oxygen (DO) control, temperature control, in-line biomass probe for growth measurements.

3) The bioreactor control system shall accommodate running and controlling a minimum of 6 pumps.

4) The bioreactor control system shall accommodate measurement of 3 additional balances besides the platform balance from which the bioreactor bag mass is measured.

5) The single use bioreactor bag shall facilitate adequate sparging and agitation.

6) The single use bioreactor bag shall accommodate a minimum of 8 inlets for various additions and 6 or more outlets for accommodating flow cells, harvest, manual sampling, auto-sampling etc.

7) The single use bioreactor bag shall be customizable for future requirements.

8) The bioreactor control system/software shall be compatible to send the data to a historian.

9) The Bioreactor installation shall follow personnel be training at the facility.

10) The bioreactor control system software shall come with various cell culture recipes and also amenable to modify to the requirement of cell culture.

Other Considerations:

• Pricing shall include shipping and installation cost, an optional year maintenance agreement as specified below.

• Vendor Proposal shall include site-preparation information required for proper system operation and maintenance, including physical space footprint, ventilation, clearance requirements, noise outputs, and IT/network requirements.

• Full system software and peripheral installation (if applicable)

• On-site software training to the extent necessary

***** IT PURCHASING REQUIREMENTS:

NOTE to Contractor: Before the task order is awarded, FDA is required to get pre-approval of all the IT hardware and/or software-firmware-freeware from the FDA Chief Information

Officer (CIO). For IT hardware, this includes any device that processes or stores data, or is controlled by data (computers/data switches, etc.), but does not include passive hardware

(rack, network cables, power supplies/cords, etc.). This will require the applicable Vendor to provide a complete list of hardware and/or software-firmware-freeware that the

Vendor will use in fulfilling this task order.

This list will need to include:

1. IT hardware: manufacture, nomenclature and model number

2. Software (all types): manufacture, nomenclature and version number

Item(s) rejected by the CIO will need to be changed and the replacement item(s) would need to go through the same approval process.

End-User Training

The proposal shall include an on-site multi-day training for 4-5 users, covering instrument operation, data acquisition software, and basic instrument maintenance, to be scheduled after the instrument has been accepted and CDER operators have become familiar with the system. This training session will be arranged by CDER technical point of contact. This multi-day training is to be at least 4 days in duration and will take place within the warranty period (within one year of date of acceptance).

Warranty and Maintenance The entire system shall be warranted for parts and labor for at least 12 months from the date of acceptance. Warranty service shall include the following at the minimum:

• Coverage shall include troubleshooting capabilities based on complete knowledge of the entire instrument, immediate access to certified replacement parts, and immediate access to improvements and new procedures provided by the original vendor and manufacturer.

• Any necessary service shall be provided by service engineers who are trained and certified by the original manufacturer of the instrument. Engineers shall have access to the manufacturer’s latest technical developments, repair procedures, application updates, diagnostic software, and planned maintenance procedures.

• The Technical Point of Contact (TPOC) or their designee shall have access to the manufacturer’s technical assistance call center during regular business hours (10am to 8pm EST). The technical assistance call center shall be staffed by engineers who provide a high level of expertise for troubleshooting the instrument.

• The vendor shall be able to guarantee that a service engineer will be able to work on site within two (2) business days of receiving a call from CDER. Upon the on-site visit, the contractor shall assess the scientific equipment and determine if the repairs needed to the scientific equipment are covered under the current service maintenance agreement. If the repairs are not covered under the service maintenance agreement, the contractor shall submit a quote to the Government for review and approval or negotiation, which shall include travel costs, parts costs and labor costs. Turnaround time for an emergency or non-emergency on-site visit to completion of repairs shall not exceed five (5) business days (120 hours).

o For repairs up to $2,500, not covered by the Maintenance/Support Agreement, the Government shall pay the vendor (with proper Government approvals) with a Government Purchase Card o For repairs over $2,500, not covered by the Maintenance/Support Agreement, the Government will issue a Purchase Order for the repairs o Repair work that is not covered by the Maintenance/Support Agreement is not to be initiated by the vendor unless the Government has given the vendor proper authorization

• All software updates to the scientific instrument and/or system software and related installation of such instrument updates and/or system software during the Agreement Term.

• The vendor shall provide all travel, labor, and parts required at no additional charge.

Option Year Maintenance Agreement:

The contractor shall propose an option year maintenance agreement covering maintenance of the instrument for a period of up to four years; four one-year option years. The maintenance agreement shall cover the same requirements as the warranty requirements with the addition of a preventative maintenance service meeting the requirements below.

• There shall be one scheduled preventative maintenance visit per year over the term of the contract. Preventative Maintenance (PM) visit shall include all travel, labor, and parts included.

This inspection shall include routine preventative maintenance of the instrument, calibration, electrical safety testing and any other preventative maintenance measures deemed necessary by the vendor.

Certificate of Maintainability:

At such time as the services of the Contractor are terminated, expire contractually or are otherwise not extended, or upon request by the Contracting Officer at any time, the Contractor shall issue, within five

(5) working days, a "Certificate of Maintainability" for any or all equipment acquired and/or maintained under this contract. The certificate shall state that preventive maintenance in accordance with the specifications of the Original Equipment Manufacturer (OEM) has been performed and that the equipment is performing in accordance with the OEM's specifications such that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any one-time charges (including but not limited to repair or inspection charges) if such maintenance were assumed effective the day after the Contractor's performance ceases. The Contractor is responsible for bearing all costs associated with obtaining such certification at no separate charge to the Government. Should the Contractor fail to issue the required Certificate of Maintainability in accordance with this clause, or should any equipment fail to perform in accordance with the certification, the Contractor shall be liable to the Government for any reasonable costs incurred by the Government for the purpose of bringing the equipment up to the required OEM maintenance level. If equipment is acquired under this contract, without maintenance of such equipment being concurrently acquired under the contract, the Contractor shall issue a Certificate of Maintainability for such equipment at the time of delivery for each piece of equipment. The certificate shall state that the equipment is in such condition that the OEM (or the OEM's successor in interest) would commit that it would assume maintenance of the equipment without billing any charges to the Government. All charges required to, obtain the requisite performance of the equipment, up to the later of the time the equipment is accepted by the Government or the warranty expires shall be borne by the

Contractor. The time the equipment is accepted by the Government is the date that the Government determines that the equipment has passed acceptance testing, not the effective date of acceptance. The fact that the equipment may have been acquired with a warranty does not relieve the Contractor of its obligations under this clause.

Acceptance:

Prior to final acceptance, the contractor will demonstrate upon installation that the item will meet all performance specifications by the manufacturer using supplied controls. Additionally, a verification run will be conducted to assess data generation capability and data quality using prepared research samples.

Period of Performance:

Base Period: 08/31/2022 – 08/30/2023 Option Year 1: 08/31/2023 – 08/30/2024 Option Year 2: 08/31/2024 – 08/30/2025 Option Year 3: 08/31/2025 – 08/30/2026 Option Year 4: 08/31/2026 – 08/30/2027

Installation and Delivery:

The vendor will be responsible for installation and setup of the instrument. Delivery hours are 10:00 am

– 4:00 pm, Monday – Friday, excluding Federal holidays and weekends. Installation shall be performed by a currently trained technician, certified by the manufacturer.

All installation costs shall be included in the proposal including, but not limited to: delivery, uncrating, placement, and setup of the instrument in the installation location, required installation kits and standards. The complete installation should be scheduled within thirty (30) days of delivery of all necessary components. The vendor shall provide any predefined specifications or requirements for the installation as part of the proposal information.

The items need to be delivered to:

U.S. Food and Drug Administration Center for Drug Evaluation and Research Division of Product Quality Research 10903 New Hampshire Avenue White Oak Building 62 Loading Dock Silver Spring, MD 20993

Government Holidays:

a. The Government hereby provides notification that Government personnel observe the listed days as holidays:

(1) New Year's Day (6) Labor Day

(2) Martin Luther King's Birthday (7) Columbus Day

(3) President’s Day (8) Veterans' Day

(4) Memorial Day (9) Thanksgiving Day

(5) Independence Day (10) Christmas Day

b. In addition to the days designated as holidays, the Government observes the following days:

(1) Any other day designated by Federal Statute

(2) Any other day designated by Executive Order

(3) Any other day designated by the President’s Proclamation

c. When any such day falls on a Saturday, the following Monday is observed. Except for designated around-the-clock or emergency operations, Contractor personnel will not be able to perform on-site under this contract with FDA on holidays set forth above. The Contractor will not charge any holiday as direct charge to the award.

d. It is understood and agreed between the Government and the Contractor that observance of such days by Government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation except as set forth within the award.

e. Nothing in this clause abrogates the rights and responsibilities of the parties relating to stop work provisions as cited in other sections of this contract.

Evaluation and Award:

Best Value

The Government intends to evaluate proposals and, if necessary, conduct discussions with all responsible Offerors within the competitive range. The award will be made to the Offeror whose proposal conforms to the terms and conditions of the solicitation and award may be made to other than the lowest priced or the highest technically rated offer.

The Government will base the determination of best value on performance, and the other evaluation factors identified elsewhere in this solicitation. The determination of best value also considers the relative importance of the evaluation factors. Technical factors and past performance when combined are significantly more important than price. It is pointed out; however, should technical competence between Offerors be considered approximately the same, then price could become primary.

FDA will base its award decision using a best value analysis that results in the most advantageous acquisition for the Government. FDA’s acquisition strategy used to obtain best value may result in an award to other than the lowest priced, technically rated Offeror. Best value analysis spans a continuum from the lowest priced, technically acceptable proposal to those proposals in which price, past performance, and each Offeror’s technical solution is evaluated.

INSTRUCTIONS TO OFFEROR FOR PROPOSAL SUBMISSION

Instructions to Offerors—Commercial Products and Commercial Services (Nov 2021)

PROPOSAL SUBMISSION FORMAT:

***Proposal shall be in 2 volumes: 1 Technical and 2 Price. The volumes shall be separate and complete.

The volumes shall be separate and complete, so that evaluation of one may be accomplished independently of, and concurrently with, the evaluation of the other. No pricing information shall be provided in volume 1.***

Quotes should explain why and how their instrument meets or exceeds each detailed technical requirement, and include supportive data and descriptions wherever possible.

The total number of pages for the technical quote shall not exceed ten (10) pages, using 1” margins, single spaced, font type Time New Roman, and a font size of 12.

***The solicitation does not commit the Government to pay any cost for the preparation and submission of a quote or proposal. It is also advised that the Contracting Officer (CO) is the only individual who can legally commit and obligate the Government to the expenditure of public funds in connection with the proposed acquisition.***

QUESTIONS DEADLINE: Interested offerors shall submit questions electronically to Linda.Troutman@fda.hhs.gov no later than June 6, 2022 at 10:00 a.m. Eastern Standard Time. Please include the company name, FDA solicitation number, and “Question(s)” in the subject line.

No Phone Calls Please.

QUOTES DUE: All quotes are due, via email to Linda.Troutman@fda.hhs.gov no later than June 13, mailto:to%20Linda.Troutman@fda.hhs.gov mailto:to%20Linda.Troutman@fda.hhs.gov

10:00 a.m. Eastern Standard Time. Please list the solicitation number FDA-SOL-FY22- 1251866 in the subject line of the email.

PROVISIONS and CLAUSES:

The Full text of the Federal Acquisition Regulation (FAR) can be accessed on the internet at https://www.acquisition.gov/far/

The following provisions and clauses apply: FAR 52.212-1, Instructions to Offerors Commercial Items;

FAR 52.212-2, Evaluation-Commercial Items; FAR 52.212-3 Offeror Representations and Certifications- Commercial Items; FAR 52.212-4, Contract Terms and Conditions Commercial Item; FAR 52.212-5, Contract Terms and Conditions Required to Implement Statutes Or Executive Orders--Commercial Items;

52.211-6 Brand Name or Equal; FAR 52.217-5, Evaluation of Options; FAR 52.217-8, Option to Extend Services; 52.217-9, Option to Extend the Term of the Contract; FAR 52.219-6, FAR 52.219-8,; FAR 52.222- 3, Convict Labor; FAR 52.222-19, Child Labor--Cooperation with Authorities and Remedies; FAR 52.222- 21, Prohibition of Segregated Facilities; FAR 52.222-26, Equal Opportunity; FAR 52.222-36, Affirmative Action for Workers with Disabilities; FAR 52.232-18 Availability of Funds; FAR 52.232-33 Payment by Electronic Funds Transfer—System for Award Management; Parties responding to this solicitation may submit their offer in accordance with their standard commercial practices (e.g. on company letterhead, formal quote form, etc) but shall include the following information: 1) company’s complete mailing and remittance addresses 2) discounts for prompt payment if applicable; 3) Dun & Bradstreet number; 4) Taxpayer ID number; 5) Catalog or Published Price Listing applicable to the service; 6) Offerors shall meet specifications as noted in the synopsis. Offerors shall include a completed copy of the provision at 52.212-3, Offeror Representations and Certifications/Commercial Items with their offer. Note:

Contractor shall be registered and active in the System for Award Management (SAM) prior to the award of a contract. You may register by going to www.sam.gov.

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352.232-71 Electronic Submission of Payment Requests (FEB 2022)

(a) Definitions. As used in this clause—

Payment request means a bill, voucher, invoice, or request for contract financing payment with associated supporting documentation. The payment request must comply with the requirements identified in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract.

(b) Except as provided in paragraph (c) of this clause, the Contractor shall submit payment requests electronically using the Department of Treasury Invoice Processing Platform (IPP) or successor system.

Information regarding IPP, including IPP Customer Support contact information, is available at www.ipp.gov or any successor site.

(c) The Contractor may submit payment requests using other than IPP only when the Contracting Officer authorizes alternate procedures in writing in accordance with HHS procedures.

https://www.acquisition.gov/far/ http://www.sam.gov/

(d) If alternate payment procedures are authorized, the Contractor shall include a copy of the Contracting Officer's written authorization with each payment request.

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FDA Electronic Invoicing and Payment Requirements - Invoice Processing Platform (IPP) (Jan 2022)

a. All Invoice submissions for goods and or services must be made electronically through the U.S.

Department of Treasury’s Invoice Processing Platform System (IPP).

http://www.ipp.gov/vendors/index.htm

b. Invoice Submission for Payment means any request for contract financing payment or invoice payment by the Contractor. To constitute a proper invoice, the payment request must comply with the requirements identified in in FAR 32.905(b), “Content of Invoices” and the applicable Payment clause included in this contract, or the clause 52.212-4 Contract Terms and Conditions – Commercial Items included in commercial items contracts. The IPP website address is: https://www.ipp.gov.

c. (1) The Agency will enroll the Contractors new to IPP. The Contractor must follow the IPP registration email instructions for enrollment to register the Collector Account for submitting invoice requests for payment. The Contractor Government Business Point of Contact (as listed in SAM) will receive Registration email from the Federal Reserve Bank of St. Louis (FRBSTL) within 3 – 5 business days of the contract award for new contracts or date of modification for existing contracts.

(2) Registration emails are sent via email from ipp.noreply@mail.eroc.twai.gov. Contractor assistance with enrollment can be obtained by contacting the IPP Production Helpdesk via email to IPPCustomerSupport@fiscal.treasury.gov or phone (866) 973-3131.

(3) The Contractor POC will receive two emails from IPP Customer Support, the first email contains the initial administrative IPP User ID. The second email, sent within 24 hours of receipt of the first email, contains a temporary password. You must log in with the temporary password within 30 days.

(4) If your company is already registered to use IPP, you will not be required to re-register.

(5) If the Contractor is unable to comply with the requirement to use IPP for submitting invoices for payment as authorized by HHSAR 332.7002, a written request must be submitted to the Contracting Officer to explain the circumstances that require the authorization of alternate payment procedures.

d. Invoices that include time and materials or labor hours Line Items must include supporting documentation to (1) substantiate the number of labor hours invoiced for each labor category, and (2) substantiate material costs incurred (when applicable).

e. Invoices that include cost-reimbursement Line Items must be submitted in a format showing expenditures for that month, as well as contract cumulative amounts.

At a minimum the following cost information shall be included, in addition to supporting documentation to substantiate costs incurred.

· Direct Labor - include all persons, listing the person's name, title, number of hours worked, hourly rate, the total cost per person and a total amount for this category;

· Indirect Costs (i.e., Fringe Benefits, Overhead, General and Administrative, Other Indirects)- show rate, base and total amount;

· Consultants (if applicable) - include the name, number of days or hours worked, daily or hourly rate, and a total amount per consultant;

· Travel - include for each airplane or train trip taken the name of the traveler, date of travel, destination, the transportation costs including ground transportation shown separately and the per diem costs. Other travel costs shall also be listed;

· Subcontractors (if applicable) - include, for each subcontractor, the same data as required for the prime Contractor;

· Other Direct Costs - include a listing of all other direct charges to the contract, i.e., office supplies, telephone, duplication, postage; and

· Fee – amount as allowable in accordance with the Schedule and FAR 52.216-8 if applicable.

f. Contractor is required to attach an invoice log addendum to each invoice which shall include, at a minimum, the following information for contract administration and reconciliation purposes:

(a) list of all invoices submitted to date under the subject award, including the following:

(1) invoice number, amount, & date submitted

(2) corresponding payment amount & date received

(b) total amount of all payments received to date under the subject contract or order

(c) and, for definitized contracts or orders only, total estimated amounts yet to be invoiced for the current, active period of performance.

g. Payment of invoices will be made based upon acceptance by the Government of the entire task or the tangible product deliverable(s) invoiced. Payments shall be based on the Government certifying that satisfactory services were provided, and the Contractor has certified that labor charges are accurate.

h. If the services are rejected for failure to conform to the technical requirements of the task order, or any other contractually legitimate reason, the Contractor shall not be paid, or shall be paid an amount negotiated by the CO.

i. Payment to the Contractor will not be made for temporary work stoppage due to circumstances beyond the control of U.S. Food and Drug Administration such as acts of God, inclement weather, power outages, and results thereof, or temporary closings of facilities at which Contractor personnel are performing. This may, however, be justification for excusable delays.

j. The Contractor agrees that the submission of an invoice to the Government for payment is a certification that the services for which the Government is being billed, have been delivered in accordance with the hours shown on the invoices, and the services are of the quality required for timely and successful completion of the effort.

k. Questions regarding invoice payments that cannot be resolved by the IPP Helpdesk should be directed to the FDA Employee Resource and Information Center (ERIC) Helpdesk at 301-827-ERIC (3742) or toll-free 866-807-ERIC (3742); or, by email at ERIC@fda.hhs.gov. Refer to the Call-in menu options and follow the phone prompts to dial the option that corresponds to the service that's needed. All ERIC Service Now Tickets will either be responded to or resolved within 48 hours (2 business days) of being received. When emailing, please be sure to include the contract number, invoice number and date of invoice, as well as your name, phone number, and a detailed description of the issue.

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