RFQ 36C25623Q0376 TelaBio Ovitex.pdf

Combined Synopsis/Solicitation Notice

*= Required Field Combined Synopsis/Solicitation Notice

SUBJECT* Tela Bio Ovitex Reinforced BioScaffold

GENERAL INFORMATION

CONTRACTING OFFICE’S ZIP CODE* 77056-5643

SOLICITATION NUMBER* 36C25623Q0376

RESPONSE DATE/TIME/ZONE 02-02-2023 13:00 CENTRAL TIME, CHICAGO, USA

ARCHIVE 5 DAYS AFTER THE RESPONSE DATE

RECOVERY ACT FUNDS N

SET-ASIDE

PRODUCT SERVICE CODE* 6515

NAICS CODE* 339113

CONTRACTING OFFICE ADDRESS Department of Veterans Affairs

Network Contracting Office 16

5075 Westheimer Road, Suite 750

Houston TX 77056-5643

POINT OF CONTACT*

Contract Specialist

Joel Matias

Joel.Matias@va.gov

713-791-1414

PLACE OF PERFORMANCE

ADDRESS Michael E. DeBakey VA Medical Center

2002 Holcombe Blvd.

Houston Texas

POSTAL CODE 77030

COUNTRY USA

ADDITIONAL INFORMATION

AGENCY’S URL https://www.VA.gov

URL DESCRIPTION Department of Veterans Affairs

AGENCY CONTACT’S EMAIL ADDRESS Joel.Matias@va.gov

EMAIL DESCRIPTION 36C25623Q0376 Quote

DESCRIPTION

General Information Document Type: Combined Solicitation/Synopsis

Solicitation Number: 36C25623Q0376

Posted Date: January 27, 2023

Response Due Date/Time: February 2, 2023/ 1:00 pm (CST)

Product or Service Code: 6515

Set Aside:

NAICS Code: 339113

Size Standard: 750 Employees

Point of Contact: Joel Matias - Email: Joel.Matias@va.gov

Contracting Office Address

Department of Veterans Affairs Network Contracting Office 16 Galleria Financial Center 5075 Westheimer Road, Suite 750 Houston, TX 77056-5643

Description:

This is a 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,” in conjunction with FAR Part 13.5 for Certain 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 Quotation (RFQ). The solicitation document and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC) 2023-01 (effective 12/30/2022). This competitive solicitation is being issued as Full and Open Competition.

The associated North American Industrial Classification System (NAICS) code for this procurement is 339113, with a small business size standard of 750 employees.

Contractor is required to be actively registered in the System for Award Management (SAM) and Small Business Administration (SBA). Quotes may be considered non-compliant and rejected if the Contracting Officer is unable to verify active registration status.

The MEDVAMC is requesting procurement of the Tela Bio Ovitex Reinforced BioScaffold.

See attached document(s) for additional information.

SECTION B - CONTINUATION OF SF 1449 BLOCKS

B.1 CONTRACT ADMINISTRATION DATA

1. Contract Administration: All contract administration matters will be handled by the following individuals:

a. CONTRACTOR ADMINISTRATOR:

CONTRACTOR POC NAME:

CONTRACTOR POC PHONE NUMBER:

b. CONTRACTOR ADDRESS:

EMAIL ADDRESS:

UEI No. CAGE Code:

TAX ID

GSA/FSS, NAC, SEWP Contract No (if applicable)

c. GOVERNMENT: Contracting Officer 36C256 Department of Veterans Affairs Network Contracting Office 16 5075 Westheimer Road, Suite 750 Houston TX 77056-5643

2. CONTRACTOR REMITTANCE ADDRESS: All payments by the Government to the contractor will be made in accordance with:

[X] 52.232-33, Payment by Electronic Funds Transfer—System for Award Management, or

3. INVOICES: Invoices shall be submitted in arrears: Payment for services provided under the terms of this contract will be made within thirty (30) days after completion of work and upon receipt of a properly executed invoice.

a. Invoices shall be properly prepared in accordance with FAR 52.212-4, contain sufficient details and match with the service ticket for the work rendered.

b. Invoices shall include, at a minimum, the following information:

• Purchase Order (PO) number and Contract Number

• Company Name, Address, and telephone number

• Invoice Date

• Invoice Number

• Contract Line Item Number (CLIN) covered (to include description and part numbers).

4. GOVERNMENT INVOICE ADDRESS: All Invoices from the contractor shall be submitted electronically in accordance with VAAR Clause 852.232-72 Electronic Submission of Payment Requests.

Department of Veteran Affairs Financial Service Center (FSC) e-Invoice Payment http://www.fsc.va.gov/fsc/einvoice.asp

5. ACKNOWLEDGMENT OF AMENDMENTS: The offeror acknowledges receipt of amendments to the Solicitation numbered and dated as follows:

AMENDMENT NO DATE

B.2 PRICE/COST SCHEDULE

ITEM INFORMATION

ITEM

NUMBER

DESCRIPTION OF

SUPPLIES/SERVICES QUANTITY UNIT UNIT PRICE AMOUNT

3.00 EA ________________ ________________

OVITEX 1S PERMANENT, 25X30 CM

MANUFACTURER PART NUMBER (MPN): F102462530P

LOCAL STOCK NUMBER: F10246-2530P

3.00 EA ________________ ________________

OVITEX 1S PERMANENT, 25X40 CM

MANUFACTURER PART NUMBER (MPN): F102462540P

LOCAL STOCK NUMBER: F10246-2540P

1.00 EA ________________ ________________

OVITEX CORE PERMANENT 10X20CM

MANUFACTURER PART NUMBER (MPN): F102441020P

LOCAL STOCK NUMBER: F10244-1020P

OVITEX CORE PERMANENT 16X20CM

MANUFACTURER PART NUMBER (MPN): F102441620P

LOCAL STOCK NUMBER: F10244-1620P

OVITEX CORE PERMANENT 20X20CM

MANUFACTURER PART NUMBER (MPN): F102442020P

LOCAL STOCK NUMBER: F10244-2020P

2.00 EA ________________ ________________

OVITEX 2S PERMANENT, 25X30 CM

MANUFACTURER PART NUMBER (MPN): F10248-2530P

LOCAL STOCK NUMBER: F10248-2530P

GRAND TOTAL __________________

B.3 DELIVERY SCHEDULE

***FOB Destination. All installation and shipping charges must be included in price of items.***

ITEM NUMBER

0001-0006 SHIP TO: Michael E. DeBakey VA Medical Center 2002 Holcombe BLVD Houston TX 77030-4298

USA

Warranty:

Estimated delivery after receipt of order:

FSS/GSA Contract No.

B.4 STATEMENT OF WORK

1. General Information:

The Michael E. Debakey VA Medical Center (MEDVAMC) is requesting procurement of the Tela Bio Ovitex Reinforced BioScaffold.

2. Equipment Schedule:

Product Number Product Description Quantity

F102462530P OviTex 1S Permanent, 25x30 cm 3

F102462540P OviTex 1S Permanent, 25x40 cm 3

F102441020P Ovitex Core Permanent 10x20cm 1

F102441620P Ovitex Core Permanent 16x20cm 1

F102442020P Ovitex Core Permanent 20x20cm 1

F10248-2530P OviTex 2S Permanent 25x30 2

3. Description of Work:

PARTS & TRAVEL

The Contractor shall furnish and replace parts in accordance with the manufacturer's specifications. The Contractor has ready access to all parts, including unique and/or high mortality replacement parts. All parts supplied shall be compatible with existing equipment.

The contract shall include all parts [except -if applicable - those parts specifically listed as being EXCLUDED]. The contractor shall use new original equipment manufacturer (OEM) parts. All parts shall be of current manufacture and have complete versatility with the presently installed equipment. All parts shall perform identically to the original equipment specifications. Rebuilt parts, used parts or those removed from other equipment, shall not be installed without specific approval by the CO or the designee. (The Contractor shall also list any excluded parts under the service contract).

Any services necessary to replace the equipment are covered within this contract shall be covered by the contractor and shall not be reimbursed by the Government under any conditions or circumstances.

PRIVACY/SECURITY

The contractor will not have electronic connectivity to the devices and will not have access to patient databases or receive screenshots with PHI present.

Any electronic or magnetic data storage devices such as hard drives, etc. shall be turned into the ISO. Electronic or magnetic data storage devices are not to be removed from VA property.

4. Delivery:

The Contractor shall deliver all equipment to the Michael E. DeBakey VA Medical Center, 2002 Holcombe BLVD., Houston, TX 77030. All equipment shall meet manufacturer specifications.

5. Hours of Coverage:

5.1 All work shall be conducted from Monday through Friday at 8:00a.m. – 4:30p.m., excluding Federal holidays and unless other times are arranged in advance and approved in writing by the delegated VA Point of Contact (POC). The government also observes Executive Orders, President’s Proclamation, and days designated by Federal Statute.

5.2 The government hereby provides notice, and the Contractor hereby acknowledges receipt that government personnel observe the listed days as holidays:

New Year’ Day January 01

Martin Luther King’s Birthday Third Monday in January

President’s Day Third Monday in February

Memorial Day Last Monday in May

Juneteenth Day Third Monday in June

Independence Day July 04

Labor Day First Monday in September

Columbus Day Second Monday in October

Veteran’s Day November 11

Thanksgiving Day Fourth Thursday in November

Christmas Day December 25

5.3 If the holiday falls on a Sunday, the following Monday will be observed as a national holiday. When a holiday falls on a Saturday, the preceding Friday is observed as a National holiday by U.S. government agencies, and any other day specifically declared by the President of the United States.

5.4 In addition to the days designated as holidays, the government observes the following days:

i. Any other day designated by Federal Statute.

ii. Any other day designated by Executive Order.

iii. Any other day designated by the President’s Proclamation

5.5 It is understood and agreed between the government and the Contractor that observance of such days by the government personnel shall not otherwise be a reason for an additional period of performance, or entitlement of compensation. In the event the Contractor’s personnel work during the holiday, they may be reimbursed by the Contractor, however, no form of holiday or other premium compensation shall be reimbursed either as a direct or indirect cost, other than their normal compensation for the time worked.

6. The following laws, regulations, policies, and procedures, including all subsequent changes or updates apply:

FAR Federal Acquisition Regulation

VAAR Veterans Administration Acquisition Regulation

Standards All applicable Federal, State, Local and Industry: Laws, Policies and

Standards as applicable to the proper performance afore and hereafter described.

7. GLOSSARY:

CO Contracting Officer CDR Contract Deficiency Report OEM Original Equipment Manufacturer OSHA Occupational Safety and Health Administration Business Day: A business day includes the entire 24-hour period ending at midnight, and a notice required by the regulation is effective even if given outside normal business hours.

8. Gray Market Prevention:

(a) No gray market or remanufactured items will be acceptable. Gray market items are Original Equipment Manufacturers’ (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for MEDVAMC.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents of valid purchase to obtain supplies such that the OEM’s warranty and service are provided and maintained by the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

(c.) 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 to 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 discover of such items.

9. Safety:

Due to COVID, Contractors shall provide their own Personal Protective Equipment (PPE) to ensure their safety. Safety precautions shall include, but are not limited to the following requirements:

• Occupational Safety and Health Act (OSHA)

• Applicable State and Local Safety Operation Procedures

• VA Safety Practices and Policies, VAMC standard operating procedures, and any other Federal, State, and Local regulations pertaining to the equipment listed for this contract.

• JCAHO – Joint Commission for the Accreditation of Healthcare Organizations

10. Changes to the Statement of Work:

Any changes to the SOW shall be authorized and approved only through written correspondence from the CO. A copy of each change will be kept in a project folder along with all other products of the project. Cost incurred by the Contractor through the actions of parties other than the CO shall be borne by the Contractor. During the term of this contract, medical equipment may be added or deleted from this contract as equipment is replaced, added or removed from service at the medical facility. Any such change shall be reflected in a written modification to this contract signed by the Contractor and the Contracting Officer.

END OF SOW

36C25623Q0376

SECTION C - CONTRACT CLAUSES

C.1 ADDENDUM to FAR 52.212-4 CONTRACT TERMS AND CONDITIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Clauses that are incorporated by reference (by Citation Number, Title, and Date), have 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 following clauses are incorporated into 52.212-4 as an addendum to this contract:

C.2 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/

FAR

Number

Title Date

52.204-13 SYSTEM FOR AWARD MANAGEMENT MAINTENANCE OCT 2018

52.204-18 COMMERCIAL AND GOVERNMENT ENTITY CODE

MAINTENANCE

AUG 2020

52.212-4 CONTRACT TERMS AND CONDITIONS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2021

52.212-5 CONTRACT TERMS AND CONDITIONS REQUIRED TO

IMPLEMENT STATUTES OR EXECUTIVE ORDERS—

COMMERCIAL PRODUCTS AND COMMERCIAL

SERVICES (MAY 2022) (JUL 2020) (DEVIATION)

MAY 2022

52.232-40 PROVIDING ACCELERATED PAYMENTS TO SMALL

BUSINESS SUBCONTRACTORS

NOV 2021

C.3 VAAR 852.212-70 PROVISIONS AND CLAUSES APPLICABLE TO VA

ACQUISITION OF COMMERCIAL ITEMS (APR 2020)

(a) The Contractor agrees to comply with any provision or clause that is incorporated herein by reference to implement agency policy applicable to acquisition of commercial items or components. The following provisions and clauses that have been checked by the Contracting Officer are incorporated by reference.

[X] 852.203–70, Commercial Advertising.

[] 852.209–70, Organizational Conflicts of Interest.

[] 852.211–70, Equipment Operation and Maintenance Manuals.

[] 852.214–71, Restrictions on Alternate Item(s).

[] 852.214–72, Alternate Item(s). [Note: this is a fillable clause.]

[] 852.214–73, Alternate Packaging and Packing.

[] 852.214–74, Marking of Bid Samples.

[X] 852.215–70, Service-Disabled Veteran-Owned and Veteran-Owned Small Business Evaluation Factors.

[X] 852.215–71, Evaluation Factor Commitments.

[] 852.216–71, Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–72, Proportional Economic Price Adjustment of Contract Price(s) Based on a Price Index.

[] 852.216–73, Economic Price Adjustment—State Nursing Home Care for Veterans.

[] 852.216–74, Economic Price Adjustment—Medicaid Labor Rates.

[] 852.216–75, Economic Price Adjustment—Fuel Surcharge.

[] 852.219–9, VA Small Business Subcontracting Plan Minimum Requirements.

[] 852.219–10, VA Notice of Total Service-Disabled Veteran-Owned Small Business Set-Aside.

[] 852.219–11, VA Notice of Total Veteran-Owned Small Business Set-Aside.

[] 852.222–70, Contract Work Hours and Safety Standards—Nursing Home Care for Veterans.

[] 852.228–70, Bond Premium Adjustment.

[] 852.228–71, Indemnification and Insurance.

[] 852.228–72, Assisting Service-Disabled Veteran-Owned and Veteran-Owned Small Businesses in Obtaining Bonds.

[X] 852.232–72, Electronic Submission of Payment Requests.

[] 852.233–70, Protest Content/Alternative Dispute Resolution.

[] 852.233–71, Alternate Protest Procedure.

[] 852.237–70, Indemnification and Medical Liability Insurance.

[X] 852.246–71, Rejected Goods.

[] 852.246–72, Frozen Processed Foods.

[] 852.246–73, Noncompliance with Packaging, Packing, and/or Marking Requirements.

[X] 852.270–1, Representatives of Contracting Officers.

[] 852.271–72, Time Spent by Counselee in Counseling Process.

[] 852.271–73, Use and Publication of Counseling Results.

[] 852.271–74, Inspection.

[] 852.271–75, Extension of Contract Period.

[] 852.273–70, Late Offers.

[] 852.273–71, Alternative Negotiation Techniques.

[] 852.273–72, Alternative Evaluation.

[] 852.273–73, Evaluation—Health-Care Resources.

[] 852.273–74, Award without Exchanges.

(b) All requests for quotations, solicitations, and contracts for commercial item services to be provided to beneficiaries must include the following clause:

[] 852.237–74, Nondiscrimination in Service Delivery.

C.4 VAAR 852.212-71 GRAY MARKET ITEMS (APR 2020)

(a) No gray market or remanufactured items will be acceptable. Gray market items are Original Equipment Manufacturers’ (OEM) goods sold through unauthorized channels in direct competition with authorized distributors. This procurement is for new OEM medical equipment only for VA medical facilities.

(b) Vendor shall be an OEM, authorized dealer, authorized distributor or authorized reseller for the proposed equipment/system, verified by an authorization letter or other documents from the OEM. All software licensing, warranty and service associated with the equipment/system shall be in accordance with the OEM terms and conditions.

C.5 VAAR 852.219-75 SUBCONTRACTING COMMITMENTS MONITORING

AND COMPLIANCE (JUL 2018)

(a) This solicitation includes the clause: 852.215-70 Service-disabled veteran-owned and veteran-owned small business evaluation factors. Accordingly, any contract resulting from this solicitation will include the clause 852.215-71 Evaluation factor commitments.

(b) The Contractor is advised that in performing contract administration functions, the Contracting Officer may use the services of a support contractor(s) to assist in assessing Contractor compliance with the subcontracting commitments incorporated into the contract. To that end, the support contractor(s) may require access to the Contractor's business records or other proprietary data to review such business records regarding contract compliance with this requirement.

(c) All support contractors conducting this review on behalf of VA will be required to sign an “Information Protection and Non-Disclosure and Disclosure of Conflicts of Interest Agreement” to ensure the Contractor's business records or other proprietary data reviewed or obtained in the course of assisting the Contracting Officer in assessing the Contractor for compliance are protected to ensure information or data is not improperly disclosed or other impropriety occurs.

(d) Furthermore, if VA determines any services the support contractor(s) will perform in assessing compliance are advisory and assistance services as defined in FAR 2.101, Definitions, the support contractor(s) must also enter into an agreement with the Contractor to protect proprietary information as required by FAR 9.505-4, Obtaining access to proprietary information, paragraph (b). The Contractor is required to cooperate fully and make available any records as may be required to enable the Contracting Officer to assess the Contractor compliance with the subcontracting commitments.

C.6 VAAR 852.242-71 ADMINISTRATIVE CONTRACTING OFFICER (OCT

2020) The Contracting Officer reserves the right to designate an Administrative Contracting Officer (ACO) for the purpose of performing certain tasks/duties in the administration of the contract.

Such designation will be in writing through an ACO Letter of Delegation and will identify the responsibilities and limitations of the ACO. A copy of the ACO Letter of Delegation will be furnished to the Contractor.

(End of Clause)

(End of Addendum to 52.212-4)

SECTION D - CONTRACT DOCUMENTS, EXHIBITS, OR

ATTACHMENTS

*Nothing in this section*

SECTION E - SOLICITATION PROVISIONS

E.1 ADDENDUM to FAR 52.212-1 INSTRUCTIONS TO OFFERORS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES

Provisions that are incorporated by reference (by Citation Number, Title, and Date), have 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 following provisions are incorporated into 52.212-1 as an addendum to this solicitation:

INSTRUCTIONS TO OFFERORS:

This acquisition is being procured 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,” in conjunction with FAR Part 13.5 for Certain Commercial Items, as supplemented. This solicitation is Full and Open Competition, and it includes all contract line item number(s) being requested in this solicitation. The government intends to solicit this requirement and award a subsequent contract without discussions or negotiations. Offerors are encouraged to provide their best offer initially because the opportunity to enter into discussions or to provide a better offer at a later time will not be possible. The offeror shall comply with the following conditions below when responding to this solicitation.

COMPLETING A QUOTE FOR SUBMITTAL

1) The Quoter shall complete Contract Administration and provide the name, title, address, email address and telephone number of the company/division point of contact regarding business decisions made with respect to the quote and who can contractually obligate the company.

2) The quoters shall submit a price for all CLIN of the solicitation. Provide all CLIN items listed in this solicitation that are annotated in Section B.2 Price/Cost Schedule.

3) See Section B.2 Price Cost Schedule. Pricing for each CLIN must be submitted in the proper format. The proper format consists of Quantity*Unit Price=Amount/Net Amount. In the event there is a deficiency in the calculation, the Unit Price will be held to the intended price multiplied by the Quantity. If the quoter shows only the Amount/Net Amount, but fails to enter Unit Price, the Amount/Net Amount divided by the Quantity will be held to be the intended price.

4) All quotes shall remain valid for 120 calendar days.

5) Quoters may, at the discretion of the government, be asked to provide information for clarification purposes regarding their quote. Requests for clarification of information does not constitute discussions. The quoters shall be held responsible for the validity of all information supplied in his/her quote, including information provided by potential subcontractors. Should subsequent investigation disclose that the fact and conditions were not as stated, the quote may be rejected and received no further consideration.

6) All services shall be performed in accordance with the Statement of Work and

36C25623Q0376.

7) Quoter must submit both Technical and Price volumes. See FAR Clause 52.212-2 Addendum for basis for award.

Contract award shall be made on the basis of lowest priced technically acceptable by the Contracting Officer. A company quote which is responsive and responsible quoter whose quote conforms to the solicitation is an acceptable response to this solicitation.

Quote Submission Guidance: Due date for submission of quotes is February 2, 2023, by 1:00 pm (CST). Please contact Joel Matias for questions or other inquiries about this solicitation via email Joel.Matias@va.gov by 1:00 pm (CST) on January 31, 2023. If questions are received an amendment to this request for quote will be posted with all questions and answers.

E.2 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/

FAR

Number

Title Date

52.204-7 SYSTEM FOR AWARD MANAGEMENT OCT 2018

52.204-16 COMMERCIAL AND GOVERNMENT ENTITY CODE

REPORTING

AUG 2020

52.212-1 INSTRUCTIONS TO OFFERORS—COMMERCIAL

PRODUCTS AND COMMERCIAL SERVICES

NOV 2021

52.229-11 TAX ON CERTAIN FOREIGN PROCUREMENTS—NOTICE

AND REPRESENTATION

JUN 2020

E.3 52.204-24 REPRESENTATION REGARDING CERTAIN

TELECOMMUNICATIONS AND VIDEO SURVEILLANCE SERVICES OR

EQUIPMENT (NOV 2021)

The Offeror shall not complete the representation at paragraph (d)(1) of this provision if the Offeror has represented that it ‘‘does not provide covered telecommunications equipment or services as a part of its offered products or services to the Government in the performance of any contract, subcontract, or other contractual instrument’’ in paragraph (c)(1) in the provision at 52.204–26, Covered Telecommunications Equipment or Services—Representation, or in paragraph (v)(2)(i) of the provision at 52.212–3, Offeror Representations and Certifications– Commercial Products and Commercial Services. The Offeror shall not complete the representation in paragraph (d)(2) of this provision if the Offeror has represented that it ‘‘does not use covered telecommunications equipment or services, or any equipment, system, or service that uses covered telecommunications equipment or services’’ in paragraph (c)(2) of the provision at 52.204–26, or in paragraph (v)(2)(ii) of the provision at 52.212–3.

(a) Definitions. As used in this provision—

Backhaul, covered telecommunications equipment or services, critical technology, interconnection arrangements, reasonable inquiry, roaming, and substantial or essential component have the meanings provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

(b) Prohibition. (1) Section 889(a)(1)(A) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2019, from procuring or obtaining, or extending or renewing a contract to procure or obtain, any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(2) Section 889(a)(1)(B) of the John S. McCain National Defense Authorization Act for Fiscal Year 2019 (Pub. L. 115–232) prohibits the head of an executive agency on or after August 13, 2020, from entering into a contract or extending or renewing a contract with an entity that uses any equipment, system, or service that uses covered telecommunications equipment or services as a substantial or essential component of any system, or as critical technology as part of any system. This prohibition applies to the use of covered telecommunications equipment or services, regardless of whether that use is in performance of work under a Federal contract.

Nothing in the prohibition shall be construed to—

(i) Prohibit the head of an executive agency from procuring with an entity to provide a service that connects to the facilities of a third-party, such as backhaul, roaming, or interconnection arrangements; or

(ii) Cover telecommunications equipment that cannot route or redirect user data traffic or cannot permit visibility into any user data or packets that such equipment transmits or otherwise handles.

(c) Procedures. The Offeror shall review the list of excluded parties in the System for Award Management (SAM) (https://www.sam.gov) for entities excluded from receiving federal awards for “covered telecommunications equipment or services.”

(d) Representations. The Offeror represents that—

(1) It [ ] will, [ ] will not provide covered telecommunications equipment or services to the Government in the performance of any contract, subcontract or other contractual instrument resulting from this solicitation. The Offeror shall provide the additional disclosure information required at paragraph (e)(1) of this section if the Offeror responds “will’’ in paragraph (d)(1) of this section; and

(2) After conducting a reasonable inquiry, for purposes of this representation, the Offeror represents that—

It [ ] does, [ ] does not use covered telecommunications equipment or services, or use any equipment, system, or service that uses covered telecommunications equipment or services.

The Offeror shall provide the additional disclosure information required at paragraph (e)(2) of this section if the Offeror responds “does’’ in paragraph (d)(2) of this section.

(e) Disclosures. (1) Disclosure for the representation in paragraph (d)(1) of this provision. If the Offeror has responded “will’’ in the representation in paragraph (d)(1) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the original equipment manufacturer (OEM) or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the Product Service Code (PSC) of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(1) of this provision.

(2) Disclosure for the representation in paragraph (d)(2) of this provision. If the Offeror has responded “does’’ in the representation in paragraph (d)(2) of this provision, the Offeror shall provide the following information as part of the offer:

(i) For covered equipment—

(A) The entity that produced the covered telecommunications equipment (include entity name, unique entity identifier, CAGE code, and whether the entity was the OEM or a distributor, if known);

(B) A description of all covered telecommunications equipment offered (include brand;

model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); and

(C) Explanation of the proposed use of covered telecommunications equipment and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(ii) For covered services—

(A) If the service is related to item maintenance: A description of all covered telecommunications services offered (include on the item being maintained: Brand; model number, such as OEM number, manufacturer part number, or wholesaler number; and item description, as applicable); or

(B) If not associated with maintenance, the PSC of the service being provided; and explanation of the proposed use of covered telecommunications services and any factors relevant to determining if such use would be permissible under the prohibition in paragraph (b)(2) of this provision.

(End of Provision)

(End of Addendum to 52.212-1)

E.4 ADDENDUM 52.212-2 EVALUATION—COMMERCIAL PRODUCTS AND

COMMERCIAL SERVICES (NOV 2021)

(a) The Government will award a contract resulting from this solicitation on the basis of the Lowest Priced Technically Acceptable (LPTA) responsible quoter whose quote, conforming to the solicitation, meets or exceeds the acceptable standards for non-cost factors. All quoters must have a current registration in the System for Award Management to be considered responsive.

Since this solicitation is Lowest Price Technically Acceptable (LPTA), the evaluation board will begin by reviewing the lowest priced quote. If the board determines that this quote is technically acceptable, no other quotes will be reviewed. This quote will have been deemed technically acceptable with the lowest price, so for this reason the award will be made based on FAR.

Please read each section below carefully for the submittals and information required as part of the evaluation. Failure to provide the requested information below shall result in the Contractor’s quote technically unacceptable. In addition, the government intends to award without discussions. The government reserves the right to request clarifications.

(b) The following factors shall be used to evaluate offers:

1. Technical

2. Price

The Contractor shall be registered in www.sam.gov to receive government contractors to be considered for award.

1. Technical – A. Contractor Qualifications:

The Contractor shall be an approved and authorized vendor, authorized distributor by the Original Equipment Manufacturer (OEM) with authorization to distribute Tela Bio Ovitex Reinforced BioScaffold.

The Contractor shall submit with technical quote an authorization letter as an approved and authorized vendor on OEM letterhead by the manufacturer as evidence of proof or submit other documents of valid purchase from the OEM to obtain supplies such that the OEM’s warranty is provided and maintained by the OEM with their technical quote by the close of the solicitation due date.

Failure to submit proof of an authorization letter or other documents of valid purchase on OEM letterhead by the manufacturer with their technical quote shall result in the technical quote as technically unacceptable.

Offeror(s) must return provision 52.204-24 with their technical quote.

Offeror(s) must return provision 52.212-3 with their technical quote. Offeror(s) may either (1) complete all relevant portions of the provision or (2) complete paragraph

(b) of the provision and indicate that is has completed official representations and certifications online at https://sam.gov

Offeror(s) acknowledgement of Solicitation Amendments.

Offeror(s) shall include supplies place of manufacture with their technical quote (include US city, state and ZIP+4; or foreign country)

Failure to provide this information may render your quote technically unacceptable.

2. Price – All line items listed in Section B.2 Price/Cost schedule must include a price.

The total evaluated price will consist of the offeror’s total proposed price in Section B.2 Price/Cost Schedule. The government may determine that an offer is unacceptable if the prices are significantly unbalanced.

(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.

E.5 52.212-3 OFFEROR REPRESENTATIONS AND CERTIFICATIONS—

COMMERCIAL PRODUCTS AND COMMERCIAL SERVICES (MAY 2022) (JUL

2020) (DEVIATION)

The Offeror shall complete only paragraph (b) of this provision if the Offeror has completed the annual representations and certification electronically in the System for Award Management (SAM) accessed through https://www.sam.gov. If the Offeror has not completed the annual representations and certifications electronically, the Offeror shall complete only paragraphs (c) through (v) of this provision.

(a) Definitions. As used in this provision—

Covered telecommunications equipment or services has the meaning provided in the clause 52.204-25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Economically disadvantaged women-owned small business (EDWOSB) concern means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States and who are economically disadvantaged in accordance with 13 CFR part 127. It automatically qualifies as a women-owned small business eligible under the WOSB Program.

Forced or indentured child labor means all work or service—

(1) Exacted from any person under the age of 18 under the menace of any penalty for its nonperformance and for which the worker does not offer himself voluntarily; or

(2) Performed by any person under the age of 18 pursuant to a contract the enforcement of which can be accomplished by process or penalties.

Highest-level owner means the entity that owns or controls an immediate owner of the offeror, or that owns or controls one or more entities that control an immediate owner of the offeror. No entity owns or exercises control of the highest level owner.

Immediate owner means an entity, other than the offeror, that has direct control of the offeror.

Indicators of control include, but are not limited to, one or more of the following: Ownership or interlocking management, identity of interests among family members, shared facilities and equipment, and the common use of employees.

Inverted domestic corporation means a foreign incorporated entity that meets the definition of an inverted domestic corporation under 6 U.S.C. 395(b), applied in accordance with the rules and definitions of 6 U.S.C. 395(c).

Manufactured end product means any end product in product and service codes (PSCs) 1000- 9999, except—

(1) PSC 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.

Predecessor means an entity that is replaced by a successor and includes any predecessors of the predecessor.

Reasonable inquiry has the meaning provided in the clause 52.204–25, Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services or Equipment.

Restricted business operations means business operations in Sudan that include power production activities, mineral extraction activities, oil-related activities, or the production of military equipment, as those terms are defined in the Sudan Accountability and Divestment Act of 2007 (Pub. L. 110-174). Restricted business operations do not include business operations that the person (as that term is defined in Section 2 of the Sudan Accountability and Divestment Act of 2007) conducting the business can demonstrate—

(1) Are conducted under contract directly and exclusively with the regional government of southern Sudan;

(2) Are conducted pursuant to specific authorization from the Office of Foreign Assets Control in the Department of the Treasury, or are expressly exempted under Federal law from the requirement to be conducted under such authorization;

(3) Consist of providing goods or services to marginalized populations of Sudan;

(4) Consist of providing goods or services to an internationally recognized peacekeeping force or humanitarian organization;

(5) Consist of providing goods or services that are used only to promote health or education;

or

(6) Have been voluntarily suspended.

Sensitive technology—

(1) Means hardware, software, telecommunications equipment, or any other technology that is to be used specifically—

(i) To restrict the free flow of unbiased information in Iran; or

(ii) To disrupt, monitor, or otherwise restrict speech of the people of Iran; and

(2) Does not include information or informational materials the export of which the President does not have the authority to regulate or prohibit pursuant to section 203(b)(3) of the International Emergency Economic Powers Act (50 U.S.C. 1702(b)(3)).

Service-disabled veteran-owned small business concern—

(1) Means a small business concern—

(i) Not less than 51 percent of which is owned by one or more service-disabled veterans or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more service-disabled veterans; and

(ii) The management and daily business operations of which are controlled by one or more service-disabled veterans or, in the case of a service-disabled veteran with permanent and severe disability, the spouse or permanent caregiver of such veteran.

(2) Service-disabled veteran means a veteran, as defined in 38 U.S.C. 101(2), with a disability that is service-connected, as defined in 38 U.S.C. 101(16).

Small business concern—

(1) Means a concern, including its affiliates, that is independently owned and operated, not dominant in the field of operation in which it is bidding on Government contracts, and qualified as a small business under the criteria in 13 CFR part 121 and size standards in this solicitation.

(2) Affiliates, as used in this definition, means business concerns, one of whom directly or indirectly controls or has the power to control the others, or a third party or parties control or have the power to control the others. In determining whether affiliation exists, consideration is given to all appropriate factors including common ownership, common management, and contractual relationships. SBA determines affiliation based on the factors set forth at 13 CFR 121.103.

Small disadvantaged business concern, consistent with 13 CFR 124.1002, means a small business concern under the size standard applicable to the acquisition, that—

(1) Is at least 51 percent unconditionally and directly owned (as defined at 13 CFR 124.105) by—

(i) One or more socially disadvantaged (as defined at 13 CFR 124.103) and economically disadvantaged (as defined at 13 CFR 124.104) individuals who are citizens of the United States;

and

(ii) Each individual claiming economic disadvantage has a net worth not exceeding $750,000 after taking into account the applicable exclusions set forth at 13 CFR 124.104(c)(2);

and

(2) The management and daily business operations of which are controlled (as defined at 13.CFR 124.106) by individuals, who meet the criteria in paragraphs (1)(i) and (ii) of this definition.

Subsidiary means an entity in which more than 50 percent of the entity is owned—

(1) Directly by a parent corporation; or

(2) Through another subsidiary of a parent corporation.

Successor means an entity that has replaced a predecessor by acquiring the assets and carrying out the affairs of the predecessor under a new name (often through acquisition or merger). The term “successor” does not include new offices/divisions of the same company or a company that only changes its name. The extent of the responsibility of the successor for the liabilities of the predecessor may vary, depending on State law and specific circumstances.

Veteran-owned small business concern means a small business concern—

(1) Not less than 51 percent of which is owned by one or more veterans (as defined at 38 U.S.C. 101(2)) or, in the case of any publicly owned business, not less than 51 percent of the stock of which is owned by one or more veterans; and

(2) The management and daily business operations of which are controlled by one or more veterans.

Women-owned business concern means a concern which is at least 51 percent owned by one or more women; or in the case of any publicly owned business, at least 51 percent of its stock is owned by one or more women; and whose management and daily business operations are controlled by one or more women.

Women-owned small business concern means a small business concern—

(1) That is at least 51 percent owned by one or more women; or, in the case of any publicly owned business, at least 51 percent of the stock of which is owned by one or more women; and

(2) Whose management and daily business operations are controlled by one or more women.

Women-owned small business (WOSB) concern eligible under the WOSB Program (in accordance with 13 CFR part 127), means a small business concern that is at least 51 percent directly and unconditionally owned by, and the management and daily business operations of which are controlled by, one or more women who are citizens of the United States.

(b)(1) Annual Representations and Certifications. Any changes provided by the Offeror in paragraph (b)(2) of this provision do not automatically change the representations and certifications in SAM.

(2) The offeror has completed the annual representations and certifications electronically in SAM accessed through http://www.sam.gov. After reviewing SAM information, the Offeror verifies by submission of this offer that the representations and certifications currently posted electronically at FAR 52.212–3, Offeror Representations and Certifications—Commercial Products and Commercial Services, have been entered or updated in the last 12 months, are current, accurate, complete, and applicable to this solicitation (including the business size standard(s) applicable to the NAICS code(s) referenced for this solicitation), at the time this offer is submitted and are incorporated in this offer by reference (see FAR 4.1201), except for paragraphs .

(c) Offerors must complete the following representations when the resulting contract is for supplies to be delivered or services to be performed in the United States or its outlying areas, or when the contracting officer has applied part 19 in accordance with 19.000(b)(1)(ii). Check all that apply.

(1) Small business concern. The offeror represents as part of its offer that it [ ] is, [ ] is not a small business concern.

(2) Veteran-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a veteran-owned small business concern.

(3) Service-disabled veteran-owned small business concern. [Complete only if the offeror represented itself as a veteran-owned small business concern in paragraph (c)(2) of this provision.] The offeror represents as part of its offer that it [ ] is, [ ] is not a service-disabled veteran-owned small business concern.

(4) Small disadvantaged business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, [ ] is not a small disadvantaged business concern as defined in 13 CFR 124.1002.

(5) Women-owned small business concern. [Complete only if the offeror represented itself as a small business concern in paragraph (c)(1) of this provision.] The offeror represents that it [ ] is, [ ] is not a women-owned small business concern.

(6) WOSB concern eligible under the WOSB Program. [Complete only if the offeror represented itself as a women-owned small business concern in paragraph (c)(5) of this provision.] The offeror represents that—

(i) It [ ] is, [ ] is not a WOSB concern eligible under the WOSB Program, has provided all the required documents to the WOSB Repository, and no change in circumstances or adverse decisions have been issued that affects its eligibility; and

(ii) It [ ] is, [ ] is not a joint venture that complies with the requirements of 13 CFR part 127, and the representation in paragraph (c)(6)(i) of this provision is accurate for each WOSB concern eligible under the WOSB Program participating in the joint venture. [The offeror shall enter the name or names of the WOSB concern eligible under the WOSB Program and other small businesses that are participating in the joint venture: ___________.] Each WOSB concern eligible under the WOSB Program participating in the joint venture shall submit a separate signed copy of the WOSB representation.

(7) Economically disadvantaged women-owned small business (EDWOSB) concern.

[Complete only if the offeror represented itself as a WOSB concern eligible under the WOSB Program in (c)(6) of this provision.] The offeror represents that—

(i) It [ ] is, [ ]…