A23 75N99225R00005 AMD 0001.pdf

(x)

75N99225R00005 x x copies of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted ; or (c) By separate letter or electronic communication which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGEMENT TO BE

RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATE SPECIFIED MAY RESULT IN REJECTION OF YOUR

OFFER. If by virtue of this amendment you desire to change an offer already submitted , such change may be made by letter or electronic communication, provided each letter or electronic communication makes reference to the solicitation and this amendment, and is received prior to the opening hour and date specified.

x

ARPA-H

Washington, MD 20005 Suite 1200 West 1304 K Street NW NIH Advanced Research Projects Ag

03/28/20250001

13. THIS ITEM ONLY APPLIES TO MODIFICATION OF CONTRACTS/ORDERS. IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

12. ACCOUNTING AND APPROPRIATION DATA (If required) is not extended.is extended, Items 8 and 15, and returning

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended , by one of the following methods: (a) By completing

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

FACILITY CODE CODE

10B. DATED (SEE ITEM 13)

10A. MODIFICATION OF CONTRACT/ORDER NO.

9B. DATED (SEE ITEM 11)

9A. AMENDMENT OF SOLICITATION NO.

CODE

8. NAME AND ADDRESS OF CONTRACTOR (No., street, county, State and ZIP Code)

7. ADMINISTERED BY (If other than Item 6)CODE 6. ISSUED BY

PAGE OF PAGES

4. REQUISITION/PURCHASE REQ. NO.3. EFFECTIVE DATE2. AMENDMENT/MODIFICATION NO. 5. PROJECT NO. (If applicable)

1. CONTRACT ID CODE

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT

03/27/2025

CHECK ONE A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority) appropriation data, etc.) SET FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

E. IMPORTANT: Contractor is not is required to sign this document and return __________________ copies to the issuing office.

ORDER NO. IN ITEM 10A.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

This amendment includes the following changes:

a. Changes to Section M - Evaluation factors for award.

All changes are represented by red font.

All other information, terms, and conditions remain unchanged.

Period of Performance: 07/01/2025 to 06/30/2030

16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)15A. NAME AND TITLE OF SIGNER (Type or print)

15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 15B. CONTRACTOR/OFFEROR 16C. DATE SIGNED

(Signature of person authorized to sign) (Signature of Contracting Officer)

CLARE E. SANCHEZ

STANDARD FORM 30 (REV. 11/2016)

Prescribed by GSA FAR (48 CFR) 53.243

Previous edition unusable

Except as provided herein, all terms and conditions of the document referenced in Item 9 A or 10A, as heretofore changed, remains unchanged and in full force and effect .

Section M – Evaluation factors for award

FAR 52.212-2 Evaluation – Commercial Products and Commercial Services (Nov 2021)

(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 shall be used to evaluate offers:

(i) Factor A: Past Performance

(ii) Factor B: Assay Testing Verification

(iii) Factor C: Narrative Responses

(iv) Factor D: Price

Factors B and C are equal. Factors B and C, when combined, are significantly more important than Factor D (Price); however, the importance of Factor D will increase as the non-price factors become equal. Factor A must be rated as Pass to be awarded a contract. Factors B and C must be rated as Acceptable or above to be awarded a contract. Factor D will be evaluated for fair and reasonableness.

Proposals will be evaluated as follows:

Factor A: Past Performance

The Government will evaluate the degree of confidence it has in an Offeror’s ability to perform services that meet the Government’s needs, based on a demonstrated record of performance. Performance confidence is assessed at the overall past performance factor level after evaluating aspects of the Offeror’s recent and relevant past performance. The Government may obtain past performance information from any source available to the Government, to include, but not limited to, Offeror submitted Summaries, Contractor Performance Assessment Reporting System (CPARS), Federal Awardee Performance and Integrity Information System (FAPIIS), Electronic Subcontract Reporting System (eSRS), or other databases; interviews with Program Managers, Contracting Officers, and Fee Determining Officials.

Recency Assessment:

An assessment of the past performance information will be made to determine if it is recent. To be recent, the effort must be ongoing or must have been performed during the past three (3) years from the date of issuance of this solicitation. Past performance information that fails this condition will not be evaluated.

Note: If any part of the performance falls within the past three years, the contract in its entirety may be considered/evaluated for past performance.

Relevancy Assessment:

The Government will conduct an evaluation of recent performance information obtained. For each recent past performance reference reviewed, the relevance of the work performed will be assessed. A relevancy determination of the Offeror’s past performance will be made based upon similarity in scope, size, and complexity to the current requirement. The past performance information obtained from other sources may be used to establish the degree of relevancy of past performance. The Government will use the following degrees of relevancy when assessing recent, relevant contracts.

The Government reserves the right to give greater consideration to information on those contracts deemed most relevant to the effort described in this solicitation. Past performance relevancy will be evaluated in accordance with Table 1.

Table 1.

Rating Definition Very Relevant Present/past performance effort involved the same scope and size of effort and complexities this solicitation requires.

Relevant Present/past performance effort involved similar scope and size of effort and complexities this solicitation requires.

Somewhat Relevant

Present/past performance effort involved some of the scope and size of effort and complexities this solicitation requires.

Not Relevant Present/past performance effort involved little or none of the scope and size of effort and complexities this solicitation requires.

Contracts actions receiving a Relevant or Very Relevant rating will receive a “Acceptable” rating. Contract actions evaluated as Somewhat Relevant or Not Relevant will receive a “Unacceptable” rating. An “Acceptable” rating will be given a “Pass”. An “Unacceptable” rating will be given a “Fail”. Offerors receiving a “Fail” rating will not be evaluated further.

Factor B: Assay Testing Verification

The Government will evaluate the Offeror’s Attachment 2 to determine if the Contractor has the network of Assay Testing Labs as required for this contract. The Government will assess the Attachment 2 for a minimum capability to perform required assay testing IAW PWS 5.5.2. Additional license verification pages provided will be utilized to verify the validity of Attachment 2 contents. Criteria provided in Attachment 2a Assay Testing Requirements shall be utilized when evaluating the Offeror’s testing capabilities. Offeror’s providing incomplete tables will receive an “Unacceptable” and not be evaluated further. Inclusion of cfMeDIP-seq assay is optional and not required for table completion. Offeror’s not providing CLIA-certified lab licenses will receive an “Unacceptable” and not be evaluated further. Offeror’s responses that contain “no” in the CLIA-certified lab column for whole exome sequencing, whole transcriptome sequencing, and ctDNA-seq will receive an “Unacceptable” and not be evaluated further.

It is preferred that the Offeror has a CLIA-certified lab for ctDNA methylome and/or cfMeDIP-seq assay types. It is strongly preferred that the Offeror provides a lab with capability to perform cfMeDIP-seq assay types. It is strongly preferred that only one lab perform each type of assay. It is strongly preferred that an IVD testing platform is used.

The table will be evaluated as a whole and given a single adjectival evaluation rating.

Reference Table 2.

Table 2. Adjectival Ratings:

Rating Definition

Outstanding (O): The Offeror’s demonstrated experience shows an exceptional level of understanding of the evaluated tasks. Proposal contains strengths1 and no weaknesses2. Risk of unsuccessful performance is very low.

Good (G): The Offeror’s demonstrated experience shows a thorough level of understanding of the evaluated tasks. Proposal contains strengths which far outweigh any weaknesses. Risk of unsuccessful performance is low.

Acceptable (A): The Offeror’s demonstrated experience shows an adequate level of understanding of the evaluated tasks. Strengths offset weaknesses or weaknesses would have no more than a moderate impact on contract performance. Risk of unsuccessful performance is no worse than moderate.

Unacceptable (U):

The Offeror’s demonstrated experience does not show an adequate level of understanding of the evaluated tasks. Proposal contains one or more deficiencies3, or proposal contains significant areas of weakness.

Risk of unsuccessful performance is very high, and the contract is unawardable.

1 A strength is an aspect of proposal that exceeds specified performance or capability requirements in a way that is advantageous to the Government during contract performance.

2 A weakness is a flaw in the proposal that increases the risk of unsuccessful performance.

For example, a lack of clarity that hinders an evaluator's understanding is a weakness.

3 A deficiency is a material failure of the proposal to meet the Government’s requirement, or a combination of weaknesses in the proposal that increase the risk of unsuccessful contract performance to an unacceptable level.

Factor C: Narrative Responses

The Government will evaluate the Offeror’s responses to Question #1 in Addendum 52.212-1(b)(21)(i) to determine the expertise in management of electronic health records and diverse clinical data across a diversity of clinical trials sites and management of tissue and blood sample tests. The Government will assess the methodologies of collecting, harmonizing/processing, and transfer of data as outlined in PWS Sections 5.5.2 and 5.5.3.

The Government will evaluate the Offeror’s responses to Question #2 in Addendum 52.212-1(b)(21)(ii) to determine the Offerors capability to rapidly transition tissue/blood biomarkers into clinical tests for patients. The Government will assess the Offeror’s strategic approach and regulatory status of the proposed testing platform, steps for test regulatory approvals, and the Offeror’s approach to minimize schedule/risks when achieving those approvals.

All Responses will be evaluated as a whole and given a single adjectival evaluation rating. Reference Table 2.

Factor D: Price

If the Offeror receives other than an “Unacceptable” or “Fail” ratings under Factor A, B, and C, then price analysis shall be performed under Factor D: Price.

The Offeror will be evaluated on the fairness and reasonableness of the Total Evaluated Price (TEP). The Government will determine whether pricing is fair and reasonable based on one or more of the techniques listed at FAR 15.404-1 or using other pricing techniques and procedures.

The Government will calculate the TEP for each Offeror. This figure will represent the Offeror’s proposal under Factor C in the best value trade-off. The Government will calculate the TEP as follows:

The TEP will be the sum of the following components: 1) the Offeror’s proposed FFP and T&M amounts, 2) the Government’s input plug number.

The Government will then add together the total extended pricing, including extension period, for all sets of rates and hours to obtain the TEP. The FAR 52.217-8 extension period shall be evaluated at an amount of one-half of the yearly total of the final option period (i.e., equal to six months of performance).

(b) Options. The Government will evaluate offers for award purposes by adding the total price for all options to the total price for the basic requirement. The Government may determine that an offer is unacceptable if the option prices are significantly unbalanced. Evaluation of options shall not obligate the Government to exercise the option(s).

(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.

(d) ARPA-H support Contractors may access source selection and contract-related information. Support Contractors have appropriate NDAs in place to support ARPA-H activities.