DDocusign Envelope ID: 2576827A£F25-4987-8812-FOIARSF e353 THIS CONTAAGT IS A RATED ORDER RATINGS PAGE OF PAGES AWARD/CONTRACT UNDER Deas CPR, > Ser % GONTRACT (Pent er) NO- 3 EFFECTIVE DATE {4 REQUSIT/ONPURGHASE REQUEST PRGLEGT NO. "7530120007986 05/04/2020 dosevcne-2020-45618 S SSUED EY oot [azis '. ADMINISTERED BY (fathertan tem 5) ‘cone [e218 Centers for Disease Control and Prevention (BG) | Centers for Disease Control and Prevention (DC) Ostice of Acquisition services (ONS) Office of Acquisition Services (OAS) 2500 Rosdceck Siva, HS TCU-a 2500 Rosdcock Siva, HS TCU-4 Atlanta, a 30341-4008 Atlanta, cA 30341-4004 toed Farm ada 7 RAE RID ADRESS OF CONTARGTOR s,s ay, Se ad BP a) = DELNERY estat, me [ros onin [x] orHER (see botm 1600 RRSEARCH Biv 7 DBGOUNT FOR PROMPT PATENT ROCKVILLE, MD 20850-2129 — 7ST RVOKSES Te Booms moot meester Soe SISTED FACLTYGOOE Roaaeee Seon Ti. HP TORARK FOR TOE TE PRTENT WL BE WADE BY cone [asa Centers for Disease Control and Prevention (EHO) Fo Sox 15980. ¢04-716-8100 Atlanta, GA 20333-0080 {3 RUTWORIT FOR GTHER THN FAL AND OPEN COWPETTON Ti ACCOUAITNG AND APPROPRIATION OATA Dousezsoex » Clarusczssyey > (x4) eA EWN. 78, SUPPLESSEAMCES 766. GUANTTTY | 160_UNIT [186 UNIT PAIGE | 16e AWOUNT ERK 20-15-1069 15G. TOTAL AMOUNT OF CONTRACT D> $ 51, 743,949.00 STABLE OF CONTENTS () SEC. DESCRIPTION "AGE(SI] () [| SEC. DESCRIPTION PAGE(S) Pam THe SCHEDULE PARTIE CONTRAGT GAGRES [Da [Sanerarioweonraner Font TET [eommaer cianses = Te SUPPLIES GR SERVICES aND PRIGESICOSTS [> TARi-UST OF DOCUMENT, EUSTS AS OTHER ATTA 7] DESCRIPTION'SPECS. WORICSTATEMENT ST Lust oF arraGrENTS za 7B [PACKAGING AND MARKING i ANT AEPRESERTATONS AWD RSTROCTONS TE [INSPEGTION AND AGCEPTANGE a | REPRESENTATIONS CERTIFICATIONS Ano x_| FJ DELIVERIES OR PERFORMANCE 18 OTHER STATEMENTS OF OFFERORS "6 [GON RAGT ADMINISTRATION DATA 33 _[IISTRS., CONDS, AND NOTIGES To OFFERORS "IDF [ SPECIAL CONTRACT AFGUIEMENTS 28 TL EVALUATION FACTORS FOR AWARD ‘CONTRACTORS NEGOTIATED AGREEMENT (Contantorlrequred toxins document and rela | copies fo esuing fice.) Contactor apeas totum and aber al tere or perom al he canveee eat eth ‘ihernseertted above ard on any continuation shee he consideration salod fein. The nights and cbigatons of pares to is eanact shal be sj eared overed by the allowing docurnerts ts awarcortrac (9) te soatn, Fay froig mh rover,roanters crear, rd sonhesony, “8A. NAME AND TITLE OF SIGNER (Type or rin) (OO) Associate Director GoNTRAGTING OFPGER WAL COMPLETE FEM ‘OR 18 AS APPLICABLE "AWARD (Gontacr eno requedo sgn tis docunont) ‘Yur or on Saison Number Incudng the ations o° changes Wad3 by you which actions or changes are Satforh fl above. ic neeoyaecootd a fo he Kom sted above ana on ay Continuation aneta Tha aut conaurmste the contact aheh const he ‘otoning documents: (0) be Govern soctaten ar your oer, and (2) hs ‘wearin! No rer coir ecient nessa. 7K, NAME OF CONTRACTING OFFER William Brannen TBEL_NAME OF CONTRACTOR 780. DATESIONED ORL UNITED STATES OF AMERICA, 706. BATE SIGNED oft me, fs 5/4/2020 by Wiliam Brannan Serr" Oe ans lem ame Teen SRMDARD FORE REY FT Bre ious EoNnow GNUSAGLE esr Becreecby cen FAR (08 CFR) S5214(2)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 2 of 37 Section B - Supplies Or Services and Prices/Costs TTEM ‘SUPPLIES 7 SERVICES ‘Qry UNIT UNIT PRICE | EXTENDED PRICE ‘0001 BAA Topic 5 Establish a Virtual Network to Investigate the Trajectory of COVID-19-Related Severe Outcomes in an Electronie Cohort of Elderly Persons and Persons with High Risk Conditions. Period of Performance: 05/04/2020. 05/03/2021 Cost Plus Fixed Fee Non-Severable 1 Each’ (6)(4) ‘Line(s) OF Accounting oxy COST PLUS FIXED FEE ‘CLIN ESTIMATED COSTS. FIXED FEE TOTAL Est. CPFE ‘001 NeDDosusign Envelope IO: 2576827A-EF35-4367-8812-F03A85F 83528 Page 3 of 37 Section C - Description/Specification/Work Statement Establish a Virtual Network to Investigate the Trajectory of COVID-19-Related Severe ‘Outcomes in an Electronic Cohort of Elderly Persons and Persons with High Risk Conditions Statement of Work C1 Background and Need The Centers for Disease Control and Prevention (CDC) is seeking collaborators with existing protocols, procedures, and institutional review boards (IRB) approvals that have been developed for influenza studies that can be leveraged in innovative ways to adapt the research infrastructure to meet the urgent needs surrounding novel coronavirus disease (COVID-19) response. Specifically, innovative solutions are needed to modify these existing or pre-approved cohorts to conduct surveillance to identify infections with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), to assess the epidemiology of COVID-19 and to compare COVID-19 with illness associated with co-circulating influenza and other viruses. Early data suggest that individuals aged 65 and above, as well as those with underlying health conditions are especially at risk for poor COVID-19 outcomes, including hospitalization, ICU admission, and death [1]. Populations in long-term care (LTC) facilities are of interest in light of an early outbreak and resulting deaths in Washington State [2]. Furthermore, initial U.S. and international-based findings highlight the role of underlying conditions in COVID-19 related hospitalizations and ICU admissions, with a particular focus on diabetes mellitus, chronic lung disease, and cardiovascular disease [3]. There is an urgent need for a network of clinical sites with timely access to EHR data, that can identify a high-risk cohort to prospectively follow illness trajectories across settings, including ambulatory, outpatient, inpatient, and LTC while collecting details on symptoms, severity, duration, and outcomes to address this current information gap. A research data platform (RDP), such as what we have developed for the Network to Investigate the Risk of Infiuenza-Associated Outcomes and Influenza Vaccine Effectiveness Using Integrated Medical and Public Health Records (VISION), can complement observational protocols that CDC may have in process, and could be implemented in the event of academic or medical research centers limiting face-to-face active patient enrollment. Westat serves as the VISION network data coordinating center and single IRB, providing CDC with project management support and developing a standardized data platform for the collection of health and respiratory illness testing data, To facilitate a rapid start-up, we propose to extend the current VISION ROP rather than standing up a new COVID-19 platform to capture the data needed to prospectively examine some of the most difficult-to- study populations, who may experience some of the most extreme outcomes associated with COVID-19. Data submission pipelines and storage specific to COVD-19 data will be established within the VISION RDP. Identifying older individuals and those with high risk conditions requires partnerships with ‘trusted clinical sites that have the capability to not only identify patients by age andDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 4 of 37 underlying health conditions, but also to track them prospectively as they move through the health system (e.., tracking a patient from a LTC setting, to the hospital, and back to LTC). We propose building on our relationships with the current VISION study sites to rapidly stand up a COVID-19 focused data network. For the VISION project, we went through an extensive site vetting process, and have four sites that are capable of pulling needed data elements, and with whom we have existing agreements in place that will allow for the necessary rapid start-up of this data collection effort. on C2 Project Objective ooxa) C3. Scope of Work coxaDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 5 of 37 wa C4 Technical Requirements Description of work (organized by task): wwxa)DDocuSign Envelope ID: 2576827A-EF35-4387-8612-FO3ASF83538 Page 6 of 37 cone)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 7 of 37 xeDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 8 of 37 xa)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 9 of 37 (ona)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 10 of 37 cotaDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page LL of 37 omDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 12 of 37 wa cs Reporting ScheduleDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 13 of 37 Westat will submit all reports in electronic format. C6 Special Considerations Not applicable. 7 Government Furnished Property Not applicable. C8 Travel (ona) THe will occur. For planning and budgeting purposes, Westat has assumed no travel C9 References 1. Severe Outcomes Among Patients with Coronavirus Disease 2019 (COVID-19) — United States, February 12-March 16, 2020. MMWR Morb Mortal Wkly Rep. ePub: 18 March 2020. DOI: http://dx.doi.org/10.15585/mmwr.mm6912e2 2. McMichael TM, Clark $, Pogosjans S, et al. COVID-19 in a Long-Term Care Facility — king County, Washington, February 27-March 9, 2020. MMWR Morb Mortal Wkly Rep. ePub: 18 March 2020. DOI: http://dx.doi.org/10.15585/mmuwr.mm6912e1 3. Preliminary Estimates of the Prevalence of Selected Underlying Health Conditions ‘Among Patients with Coronavirus Disease 2019 — United States, February 12—March 28, 2020. MMWR Morb Mortal Wkly Rep 2020;69:382-386. DOI: http://dx.doi.org/10.15585/mmwr.mm6913e2 C.10 Deliverables Exhibit 7. Deliverables (May 4, 2020 - May 3, 2021) waDDocuSign Envelope ID: 2576827A-EF35-4387-8612-FO3ASF83538 Page 14 of 37 ox Exhibit 7. Deliverables (May 4, 2020 - May 3, 2021) (continued) ona coxaDDocuSign Envelope ID: 2576827A-EF35-4367-8612-FO3A8SF83538 Page 15 of 37 Section D - Packaging And Marking There is nothing for this section.DDocuSign Envelope ID: 2576827A-EF35-4387-8612-FO3ASF83538 Page 16 of 37 Section E - Inspection And Acceptance E.1_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 ext available. Also, the full ext ofa clause may be accessed electronically at this/these address(es) bups/ivww.aeqnet.20vDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 17 of 37 (End of Clause) FAR SOURCE ‘TITLE AND DATE, 52.246-8 Inspection of Research and Development—Cost-Reimbursement (May 2001) E.2 Inspection and Acceptance (Jul 1999) Inspection and acceptance of the articles, services, and documentation called for herein shall be accomplished by the Contracting Officer, or his duly authorized representative [who for the purposes of this contract shall be the Contracting Officer's Representative (COR)] atthe destination of the articles, services or documentation (End of Clause)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 18 of 37 Section F - Deliveries Or Performance E.1_ 52.2522 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 Orticer will make their full ext available. Also, the full text ofa clause may be accessed electronically at thisthese address(es): Iup:/www.aeqnet-gov (End of Clause) FAR SOURCE ‘TITLE AND DATE, 52.242-15 (AI 1) Stop-Work Order Ait (Apr 1984) 52.242-17 Government Delay of Work (Apr 1984) F.2 Reporting Schedule/Deliverables ‘See section C.10 of the Statement of WorkDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 19 of 37 Section G - Contract Administration Data Gal Contract Representatives Contracting Officer (CO) responsible for this contract: William Brannen Centers for Disease Control and Prevention (CDC) Office of Acquistion Services (OAS) 2900 Woodcock Blvd, MS TCU-4 Allanta, GA 30341 Telephone: 770-488-2084 E-mail: Whrannen@ede.gov Contracting Officer's Representative (COR) responsible for this contract: Mark Thompson Epidemiologist Centers for Disease Control and Prevention (CDC) National Center for Immunization and Respiratory Diseases (NCIRD) 1600 Clifton Re, Building 24, MS 24-7 Atlanta, GA 30333 Telephone: 404.639.0814 E-mail: isg8@ede.gov G2 CDCP _GO09 Contracting Officer (Jul 1999) (a) The Contracting Officer is the only individual who ean legally commit the Government to the expenditure of public funds, No person other than the Contracting Officer can make any changes to the terms, conditions, general provisions, or other stipulations of this contract. (b) No information, other than that which may be contained in an authorized modification to this contract, duly issued by the Contracting Officer, which may be received from any person employed by the United States Government, or otherwise, shall be considered grounds for deviation from any stipulation of this contract, (End of Clause) G3 CDCO_GO08 Contracting Officer's Representative (COR) (Jul 2017) Performance of the work hereunder shall be subject (othe technical directions ofthe designated COR for this contract, As used herein, technical directions are directions (o the Contractor which fill in details, suggests possible lines of inquiry, or otherwise completes the general scope of work set forth herein. These technical directions must be within the general scope of work, and may’ not alter the scope of work or cause changes of such a nature as to justify an ‘adjustment in the stated contract price/cost, or any stated limitation thereof. In the event that the Contractor believes full implementation of any of these directions may exceed the scope of the contract, he or she shall notify the originator ofthe technical direction and the Contracting Officer, immediately or 1 soon as possible, in a letter or e-mail separate of any required repor(s). No technical direction, nor its fulfillment, shall alter or abrogate the rights and obligations fixed in this contract,DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 20 of 37 “The Government COR is not authorized to change any of the terms and conditions of this contract, Contract changes shall be made only by the Contracting Orficer by properly writen modification(s) to the contract. The Government will provide the Contractor with a copy of the COR delegation memorandum upon request (End of Clause) CDCO_GO18 Payment by Electronic Funds Transfer (Feb 2018) (a) The Government shall use electronic funds transfer to the maximum extent possible when making payments tunder this contract. FAR 52.232-33, Payment by Electronic Funds Transfer System for Award Management, in Section I, requires the contractor to designate in writing a financial institution for receipt of electronic funds transfer payments, (b) Inthe case that EFT information is not within the System of Award Management, FAR 52.232-34 requires ‘mandatory submission of Contractor's EFT information directly to the office designated in this contract to receive that information (hereafter: “designated office”); see below. The contractor shall submit the EFT information within the form tiled “ACH Vendot/Miscellaneous Payment Enrollment Form" to the address indicated below. Note: The form is either attached to this contract (see Section J, List of Attachments) or may be obtained by contacting the Contracting Officer or the CDC Office of Financial Resources at 678-475-4510. (€) Incases where the contractor has previously provided such information, ie., pursuant to prior contractlorder, and been enrolled in the program, the form is not required unless the designated Financial institution has changed (@) The completed form shall be mailed after award, but no later than 14 calendar days before an invoice is submitted, 10 the following addres: “The Centers for Disease Control and Prevention Office of Financial Resources (OFR) P.O, Box 15580 Aulanta, GA. 30333, (Or ~ Fax copy to: 404-638-5342 (End of Clause) 6.5 CDC42,0003 Billing Rates (May 2015) (@) As defined in FAR Subpart 42.7, Billing Rate means an indirect cost rate established temporarily for interim reimbursement of incurred indirect costs, Billing rates may be adjusted as necessary pending establishment of fi indirect rates (b) Notwithstanding the provisions of the clause entitled Allowable Cost and Payment (AR 52.216-7), allowable indirect costs under this contract shall be determined by applying the following provisional billing rates to the bases specified below:DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 21 of 37 —_ EFFECTIVE PERIOD [eae teocation [APPLICABLE |p csp (FROM - TO) ro ca (©) The above rates are provisional billing rates only and shall apply from the date of award until such time as the rates are revised by modification, Any modification to change the above rates will aso state the effective period covered by the revised rates (@) Billing rates may be prospectively or retroactively revised by mutual agreement of the Contracting Officer and the contractor at cither party’s request. When agreement cannot be reached, the billing rates may be unilaterally determined by the Contracting Officer as set forth in FAR 42.704. (¢) Final indirect rates shall be established in accordance with FAR Clause $2.216-7, Allowable Cost and Payment As required by that clause, the contractor shall submit an adequate final indirect cost rate proposal to the Contracting Officer and auelitor within the 6 month period following the expiration of each of is fiseal years. Upon receipt of the final indisect cost rate proposal and pending the establishment of final indirect cost rates, the contractor and the Government may mutually agree to revise the provisional billing rates to reflect the proposed indirect cost rates until the proposal has been audited and settled, (End of Clause) 6.6 Billing Instructions for Negotiated Cast-Type Contracts, Reimbursement procedures related 10 negotiated cost-type contracts require that Contractors submit to the Government adequately prepared claims, The instructions that follow are provided for Contractors’ use in the preparation and submission of invoices or vouchers requesting reimbursement for work performed. The preparation of invoices or vouchers as outlined below will aid in the review and approval of claims and enable prompt payment to the Contractor. 1, Forms to Be Used Tn requesting reimbursement, Contractors may use the regular Government voucher form, Standard Form 1034, “Public Voucher for Purchases and Services Other Than Personal,” and Standard Form 1035, “Continuation Sheet,”DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 22 of 37 or the Contractor's own invoice form. Ifthe Contractor desires to use the Government's standard forms, @ request for the forms should be submitted to the Contracting Officer. Ifthe Contractor uses his own invoice, the billing must conform with the instructions set forth herein Submission of Invoices or Vouchers Invoices of vouchers shall be submitted per Section G of the contract. A original invoices or vouchers must be submitted to the Financial Management Office atthe address show below: ‘The Centers for Disease Control and Prevention Financial Management Office (FMO) P.O, Box 15580 Aulanta, GA. 30333, (Or~ ‘The Contractor may submit the original invoice/voucher or progress payment via facsimile or email: Fax: 404-638-5324 Email: FMOAPINV@CDC.GOV NOTE: Submit to only one (1) of the above locations. The contractor shall submit copies of the invoice/voucher or progress payment to the contract specialist and the Contracting Officer's Representative. “The Contractor shall include (as 2 minimum) the following information on each invoice: (1) Contractor's Name & Address (2) Contractor's Tax Kdentfcation Number (TIN) (3) Porehase Oxdcr/Contact Number ad Task Order Number, if Appropriate “ (5) Invoice Date (6) Contact Line tem Number and Description of lem (9) Quantiry (8) Unit Price & Extended Amount for each in item (9) Shipping and Payment Terms (10) Total Amount of Invoice (11) Name, title and telephone number of person tobe notified in the event ofa defective invoice (12) Payment Address, if ferent from the information above (13) DUNS +4 Number (1) The Conteactr shal, in addition to the above requirements, submit a detailed breakout of costs 28 supporting backup and shall place the following signed Contractor Certification on cach invoice voucher submitted tinder this contractDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 23 of 37 I certify that this voucher reflects (fil in Contractor's name) request for reimbursement of allowable and allocable costs incurred in specific performance of work authorized under Contract (fill in contract number)/Task (Fill-in task order number, if applicable), and that these costs are true and accurate to the best of my knowledge and belie. (Original Signature of Authorized Official) ‘Typed Name and Title of Signatory REMINDER: The original and each copy should be easily idemtiiuble. Vouchers should be collated. Failure 10 submit vouchers in the proper format will delay your payment, 3. Preparation of Invoices or Vouchers ‘EXHIBIT I~ Summary of All Costs As shown on the attached Standard Form 1034, identified as EXHIBIT I (SAMPLE), a summary of all current costs must be shown, This summary consists of alist identifying the general categories and the amounts incurred during the period covered by the billing, together with the portion of fixed fee (if any) payable for that period. The reimbursable costs incurred and the dates of the period for which the charges ‘are claimed mus fall within the period specified in the contract. EXHIBIT Il - Details of Costs Claimed As shown on the attached Standard Form 1035, identified as EXHIBIT Il (SAMPLE), a detailed breakdown must be provided to substantiate the categories shown on the summary of costs (see EXHIBIT 1). The following describes some of the categories that might appear on your billings: (Direct Labor Direct Labor costs consist of salaries and wages paid for scientific, wehnical, and other work performed directly for the contract and pursuant to the contract terms. Labor costs, excluding Fringe benefits and overtime premium pay, will be billed as follows; List the titles and amounts for employees whose salaries or wages, or portions thereof, were charged to the contract; show the rate (or hours) worked, and amount for each individual. The cost of direct labor, which is charged directly o the contract, must be supported by time records ‘maintained in the contractor's office. (Q) Fringe Benefits [fits the Contractor's established practice to treat fringe benefits asa direct cost, such costs should be billed separately asa single item. NOTE: Fringe benefits, bonuses, et. are usually treated as indirect costs for inclusion in the overhead pool; however, they may be treated as direct labor costs or as an “Other Direct Charge’ if such treatment isin accordance with the Contractor’ established accounting procedures. @) Premium Pay Premium pay isthe difference between the rates and amounts paid for overtime or shift work and amount normally paid on a straight time basis. Generally such pay is not included in the direct labor base and should not be included in the billing For “direct labor” unless the Contractor has consistently followed this practice in the past as a matter of policy. Premium pay of any kind unless provided for in the contract must be authorized by the Contracting Officer in advance, Billings for unauthorized premium pays have caused frequent delays in payment due to suspensions and exchange of correspondence. Citations of authorization for premium pay will avoid delays in payment. Authorized premium pay may be shown as a single item on the summaryDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 24 of 37 of costs. However, it must be separately itemized for each position, or job category, showing the amount, and a citation of the Contracting Officer’s letter of authorization on the continuation sheet ‘of the invoice or voucher, (4) Materials and Supplies Only those items, which the Contractor normally treats as “direct costs", should be claimed under this heading. Majo classifications of material only should be billed separately under appropriate classification. Items costing less than $25.00 may be listed by category of materials or supplies. Show the description and dollar amount of individual classifications. All such charges must be supported by the Contractor's office records, (5)Travel ‘When authorized in the contract as a direct cost, travel costs that are directly related t0 specific contract performance may be billed as a direct cost. Travel cost detail should show: (a) Name of traveler and official ttle, (b)_ Purpose of trip, (©) Dates of departure and return to starting point (station or aixpott), (@)_ Transportation costs, identified as t ral, air, private automobile (including mileage and rate) and taxi (©) _Ifclaim for subsistence is on per diem basis, show number of days, rate and amount, as authorized in contract. If claim is based on actual cost of subsistence, show, on a dally basis, the amounts elaimed for lodging and meals separately. (Reference to Contracting Officer's etter of authorization if required by contract, (6) Consultant Fees, Identify the consultant by name, number of days utilized, and amount of fee. () Equipment Nonexpendable personal property must be specifically approved in writing by the Contracting Officer or authorized by the terms of the contract. Billing data should include a description of item, make model, quantity, unit cost, total cost, and date approved by the Contracting Officer, if applicable. A copy of the vendor's bill may be submitted in lieu ofthe identifying information (8) Burden Pending establishment of final contract indirect cost rates for each of the Contractor's fiscal years, the Contractor will be reimbursed based on his submittal of provisional rates as set forth in the contract, The contract may provide for more than one type inditect east rate, such as overhead rate, and general and administrative expense rate, in which case the direct cost hases (e.g, direct labor, total direct cost, etc.) (9) Fixed Fee Ordinarily the fixed fee is stated in the contract as a lump sum and may be billed in the ratio of incurred costs to total estimated cost as set forth in the contract, with the final 15 percent to be billed on the final invoice or voucher, Contract terms govern the method of payments. EXHIBIT IIL Cumulative Amount ClaimedDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 25 of 37 As shown on the attached Standard Form 1035, identified as EXHIBIT IL] (SAMPLE), the Contractor must show the cumulative amounts claimed by categories from the contract award date through the date of the current invoice or voucher, as well as the estimated cost to complete per category. QUICK CHECKLIST FOR INVOICE SUBMISSION: : ‘Standard Forms 1034 and 1035 recommended. If submitting own forms, statement must conform to billing instructions + Quarterly billing as a minimum . Invoice or Voucher contain the minimum requirements per Invoice Submission clause per Section G of the eontract + Vouchers should be collated + Detail of Cost Claimed (Bnd of Clause)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Paxe 26 of 37 Section H - Special Contract Requirements HLL PUBLIC ACCESS TO ARCHIVED PUBLICATIONS RI RESEARCH (Nov 2018) LTING FROM CDC. All CDC-funded investigators shall submit to the National Institutes of Health Manuscript Submission System the electronic version of the authors final manuscript, upon acceptance for publication, of any peer-reviewed scientific publications resulting from research supported in whole or in part with Federal funds from the Department of Health ‘and Human Services, Centers for Disease Control and Prevention. CDC defines the author’ final manuscript as the final version accepted for journal publication, and includes all modifications from the publishing peer review process. The CDC Stacks and National Library of Medicine’s (NLM) PubMed Central (PMC) archives will preserve permanently these manuscripts for use by the public, health care providers, educators, scientists, and CDC. H.2 Certificates of Confidentiality (Nov 2018) Section 301(d) of the Public Health Service (PHS) Act, as amentled by Section 2012 of the 21st Century Cures Act, PLL, 114-255 (42 U.S.C. 241(¢)), states thatthe Secretary shall issue Certificates of Confidentiality (Certificates) to persons engaged in biomedical, behavioral, clinical, or other research activities in which identifiable, sensitive information is collected, Consistent with the statute, research commenced or ongoing after December 13, 2016 and in whieh identifiable, sensitive information is collected, as defined by Section 301(d), is deemed issued a Certificate, Consistent with the statute, CDC considers research in which identifiable, sensitive information is collected or used, to include: '* Human subjects research as defined in the Federal Policy for the Protection of Human Subjects (45 CFR Part 46), including exempt research except for human subjects research that is determined to be exempt from all or some of the requirements of 45 CER 46 ifthe information obtained is recorded in such a manner that human subjects cannot be identified or the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects: ‘+ Research involving the collection or use of biospecimens that are identifiable (0 an individual or for which there is atleast a very small risk that some combination of the biospecimen, a request fr the biospecimen, and other available data Sources could be used to deduce the idemtity of an individual; # Research that involves the generation of individual level, human genomic data from biospecimens, or the use of such data, regardless of whether the data is recorded in such a manner that human subjects can be identified or the identity of the human subjects can readily be ascertained as defined in the Federal Policy for the Protection of Human Subjects (45 CFR Part 46); or '* Any other research that involves information about an individual for which there is at least a very small risk, as determined by current scientific practices or statistical methods, that some combination of the information, a request forthe information, and other available data sources could be used to deduce the identity of an individual, as defined in subsection 301(d) of the Public Health Service Act For research covered hy a Certificate and consistent with the statute, Contractor shall not: ‘+ Disclose or provide, in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding, the name of such individual or any such information, document, or biospecimen that contains identifiable, sensitive information about the individual and that was created or compiled for purposes of theDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 27 of 37 research, unless such disclosure er use is made with the consent of the individual to whom the information, document, or biospecimen pertains; or *# Disclose or provide to any other person not connected with the research the name of such an individual or any information, document, or biospecimen that contains identifiable, sensitive information about such an individual and that was created or compiled for purposes of the research. Consistent with the statue, disclosure is permitted only in the below circumstances: # Required by Federal, State, of local laws (¢.., as required by the Federal Food, Drug, and Cosmetic Act, or sate laws requiring the reporting of communicable diseases to State and local health departments), excluding instances of disclosure in any Federal, State, or local civil, criminal, administrative, legislative, or other proceeding ‘* Necessary for the medical treatment ofthe individual to whom the information, document, or biospecime pertains and made with the consent of such individual; # Made with the consent ofthe individual to whom the information, document, or biospecimen pertains; or '* Made for the purposes of other scientific research that is in compliance with applicable Federal regulations governing the protection of human subjects in research, Contractor shall keep records of when such disclosures are made and, upon request by CDC, shall make sueh information available to CDC. Contractor shall comply with FAR Part 31, Contract Cost Principles and Procedures, as applicable, and maintain effective internal controls that provide reasonable assurance thatthe contract is managed in compliance with Federal statutes and regulations, Contractors conducting research covered by a Certificate shall ensure that any company/institution/individual not funded by CDC who receives a copy of identifiable, sensitive information protected by a Certificate is aware of the requirements of subsection 301(d) of the Public Health Service Act with respect to such information, The Contractor will secure an agreement with such company/institution/individual to ensure compliance with the requirements of the Certificate, Tn addition, Contractor shall ensure that all its employees and subcontractor employees working on this contract are informed of the substance of the abovementioned requirements and agree to comply with subsection 301() of the Public Health Service Act, Public Health Data Definition: Public Health data means digitally recorded factual material commonly accepted in the si community as a basis for public health findings, conclusions, and implementation When CDC is funding, in whole or in part, via a contract as defined in FAR 2.101, with respect to public health data, a CDC-approved Data Management Plan (DMP) ~ a plan for digital data management, sharing, and preservation is required prior to commencing any related services or work, For contracts where public health data collection or generation activities may become necessary during the period of performance (e.g. via contract modification), a DMP will be required to be submitted and evaluated during the period of performance. The DMP is a deliverable and a living document that should be updated throughout the life cycle of data. A final DMP is required at the end of the contract performance that shows where the data are deposited and how they are being made accessible or justification provided for not doing so,DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 28 of 37 Data Management Plan A.DMP for each collection and/or generation of public health data should include the following information: ‘© A description of the public health data to be collected or generated in the contract period of performance; ‘© Standards to be used for the collected or generated public health data; ‘© Mechanisms for or limitations to providing access to and sharing of the data (include a description of provisions for the protection of privacy, confidentiality, security, intellectual property, or other rights) ‘or justification for why data cannot be made accessible. This section should address access to identifiable and de-identified data (see below for additional information about # Statement of the use of data standards that ensure all released data have appropriate documentation that describes the method of collection, what the data represent, and potential limitations for use; and ‘© Plans for archiving and long-term preservation of the data, or explanation of why long-term. preservation and access are not justified. This section should address archiving and preservation of identifiable and de-idemtiied data (see below for additional information regarding archiving). Examples of Data Management Plan Templates and To University of California: http://www. cdlib.org/services/uc3/dmpt html USGS: hnip:/www.usgs. gov/datamanagement/planvamplans.php Access to and Archiving of the Data ‘To the extent that is feasible, contractors should make public health data accessible, Rights in Data clauses (FAR 52.227-14 Rights in Data ~ General, 52.227-16, Additional Data Requirements, FAR 52.227-17 Rights in Data — Special Works, or FAR 52.227-18 Rights in Data-Existing Works), may be applicable and incorporated into contracts, depending on the Statement of Work involved. The data rights clauses give the government “unlimited rights” in data first produced (when funded by government solely) in the performance of a contract. “Unlimited rights” is an unlimited license to use, disclose or reproduce the data; it does not give the government ownership of the data. Unlimited rights in data would allow the government to archive and make public non-proprietary data first produced in contract performance. Contracts that do not inelude terms for submintal of public health data to CDC, ate expected to plan and prepare for providing access to, and archiving/long-term preservation of, collected and/or generated data within the contract period of performance, as set forth below. The final version of a collected and/or generated data set intended for release or sharing should be made available within thirty (30) months after the end of the data collection or generation, except surveillance data, which should be made accessible within a year ofthe end of a collection cycle. For public use de-identified (removal of sensitive identifiable or potentially identifiable information) datasets, an accompanying data dictionary, and other documentation relevant to use of the data set should be deposited in a sustainable repository to provide access to the data. Data that cannot be de-identified can be provided as restricted data upon request under a data-use agreement or onsite controlled use For data underlying a scientific publication, the contractor shall make the data available coincident with publication of the paper, at a minimum a machine-readable version of the data tables shown in the paper, unless the data set is already available via a elease or sharing mechanism. In addition, contractors should ensure the quality of data they make accessible and seek to provide the data in a machine readable and nonproprietary format, Contractors who fail to release public health data in a timely fashion may be subject to procedures normally used to address failure 10 comply with the terms and conditions of the contract and may be grounds for the Contracting Officer to terminate the contract for default, Irrespective of whether the data are made accessible or not, Public health data of value should be preserved long-term, A final DMP is required at the end of the contract performance. The final DMP will indicate the location of the deposited data and the manner of access granted to the data, There needs to be an adequate justification for not ‘making data accessible and this justification must be documented in the DMP and approved by the Contracting Officer's Representative.DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 29 of 37 Additional i formation is available at https://vww.bhs.gov/open/publicaccess/index.html 4 HHSAR 352.239. ion Tee i 0 (a) Pursuant to Section 508 of the Rehabibitation Act of 1973 29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contactor order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at hip /www.nhs. gov web/S0S. The complete text of Section 508 Final Provisions can be accessed at hip: /www aceess- board gov/guidelines-and-standards/communications-and- ivahoutthe-section-508-standards (b) The Section 508 accessibility standards applicable to this contractor order are identified in the Statement of Work or Specification or Performance Work Statement. The contractor must provide any necessary updates to the submitted HHS Product Assessment Template(s) at the end of each contract or order exceeding the simplified acquisition threshold (see FAR 2,101) when the contract or order duration is one year or less, IFit is determined by the Government that EIT supplies and services provided by the Contractor do noi conform to the described accessibility standards in the contract, remediation of the supplies or services to the level of conformance specified {in the contract will be the responsibility of the Contractor at its own expense, (©) The Section 508 accessibility standards applicable o this contract ate: 205 WCAG 2.0 Level A & AA Success Criteria 302 Functional Performance Criteria 502 Inoperability with Assistive Technology 503 Applications 504 Authoring Tools 602 Support Documentation 603 Support Services (@) Inthe event of a modification(s) to this contract or order, which adds new EIT supplies or services or revises the type of, or specifications for, supplies or services, the Contracting Officer may require that the contractor submit a completed HHS Section S08 Product Assessment Template and any other additional information necessary toa the Government in determining that the EIT supplies or services conform to Section SO8 accessibility standueds. Instructions for documenting accessibility via the HHS Section 508 Product Assessment Template may be found under Section 508 policy on the HHS website: (huips/www.his.gov/wel’508), itis determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the contract, remediation of the supplies or services tothe level of conformance specified in the contract will be the responsibility of the Contractor at ils own expense, (€) If this is an Indefinite Delivery contract, a Blanket Purchase Agreement or a Basic Ordering Agreement, the taskldelivery order requests that include EIT supplies or services will define the specifications and accessibility standards for the order. In those cases, the Contractor may be required to provide a completed HHS Section 508, Product Assessment Template and any other additional information necessary to assist the Government in determining that the ELT supplies or services conform to Section 508 accessibility standards. Instructions for documenting accessibility via the HHS Section SO8 Product Assessment Template may be found at hutp:/wwwhhs.gov/weh/SO8. TF it is determined by the Government that EIT supplies and services provided by the Contractor do not conform to the described accessibility standards in the provided documentation, remediation of the supplies or services to the level of conformance specified in the contract will be the responsibilty of the Contractor at its own expense, (End of Clause)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 30 of 37 (a). Personal services shall not be performed under this contract. Although the Government may provide sporadic or occasional instructions within the scope of the contract, the Contractor is responsible for control and supervision of its employees. Ifthe Contractor (including its employees) believes any Government action of communication has been given that would ereate a personal services relationship between the Government and any Contractor ‘employee, the Contractor shall promptly notify the Contracting Officer of this communication of action, (b) The contractor shall comply with, and ensure their employees and subcontractors comply with, CDC Policy titled “Identification of Contractors’ Employees and Safeguarding Government Information.” No Contractor ‘employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor ‘employee shall state orally or in writing at any time that he or she i acting on behalf of the Government. In all communications with third partes in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work, . The contractor is limited to performing the services identified in the contract statement of work and shall not interpret any communication with anyone as a permissible change in contract scope or as authorization to perform work not deseribed in the contract. All contract changes will be incorporated by a modification signed by the Contracting Officer. (©) The Contractor shall ensure that all ofits employees and subcontractor employees working on this contract are informed of the substance of this clause. ‘The Contractor agrees that this is a non-personal services contract; and that forall the purposes of the contract, the Contractor is not, nor shall it hold itselTout to be an agent or partner of, oF joint venture with, the Government. The Contractor shall notify its employees that they shall neither supervise nor ‘accept supervision from Government employees. The substance of this clause shall be included in all subcontracts at any tier. (@) Nothing in this clause shall limit the Government’ rights in any way under any other provision of the contract, Including those related to te Government’ right to inspeet and accept of reject the services performed under this contract (End of Clause) H.6 CDCA_HO009 Key Personnel (Jul 2017) The key personnel cited below are considered essential to the work performed under the contract, Pursuant to the terms of HHSAR Clause 252.237-75, Key Personnel, the Contractor shall not replace or divert any of these individuals without the written consent of the Contracting Officer. Personnel Title coxa) (End of Clause) 47 HHS reserves the right to exercise priorities and allocations authority with respect to this contract, to include rating this order in accordance with 45 CFR Part 101, Subpart A—Health Resources Priorities and Allocations SystemDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 31 of 37 Section | - Contract Clauses Section I-1 - Clauses Incorporated By Reference 1 §2.252-2 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 Oficer will make their full text available, Also, the full textof a clause may be accessed electronically at this/these address(es): butp:/wwww.acqnet.g0v (End of Clause) FAR SOURCE | TITLEAND DATE 52.2021 Definitions (Nov 2013) 322033 Gratuities (Apr 1984) 52.2085 Covenant against Contingent Fees (May 2014) 52.203-6 Resiritions on Subcontractor Sales tothe Government (Sep 2006) 32.208-7 ‘AnticKickback Provedures (May 2014) 32.208-8 Cancellation, Rescission, and Recovery of Funds for Mlegal or Improper Activity (May 2014) 52.203-10 Price or Fee Adjusiment for llegal or Improper Activity (May 2014) 32.208-12 imitation on Payments to Influence Certain Federal Transactions (Oct 2010) 52.208-13 Contractor Code of Business Ethics and Conduct (Oct 2015) 32.208-17 Contractor Employee Whistleblower Rights and Requirement To Inform Employees of Whistleblower Rights (Ape 2014) 52.208-19 Prohibition on Requiring Certain Internal Confidentiality Agreements or Statements (lan 2017) 322084 Printed or Copied Double-Sided on Recycled Paper (May 2011) 52.2009 Personal Mentity Verification of Contractor Personnel (lan 2011) 32.204-10 Reporting Executive Compensation and First“Tier Subvontract Awards (Oct 2018) 32204013 System for Award Management Maintenance (Oct 2018) 32200-14 Service Contract Reporting Requirements (Oct 2016) 52.204-19 Incorporation by Reference of Representations and Certifications (Dec 2014) 52.208-23 Prohibition on Contracting for Hardware, Software, and Serviees Developed or Provided by Kaspersky Lab and Other Covered Entities (Jul 2018) S220 25: Prohibition on Contracting for Certain Telecommunications and Video Surveillance Services tor Equipment (AUG 2019) 52.209-6 Protecting the Government's Interest When Subcontracting with Contractors Debarred, Suspended, or Proposed for Debarment (Oct 2015) 322099 Updates of Publicly Available Information Regarding Responsibility Matters (Oct 2018) 32:208-10 Prohibition on Contracting with Inverted Domestic Corporations. (Now 2013) 52.2152 ANT | Audit and Records ~ Negotiation Alternate 11 (Aug2016). 322158 (Order of Precedence - Uniform Contract Format (Oct 1997) 52.215-10 Price Reduction for Defective Certified Cost or Pricing Data (Aug 2011) 3221512 Subcontractor Certified Cost or Pricing Data (Oct 2010)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 32 of 37 PRIS Pension Adjustments and Asset Reversions (Oct 2010)) 5221517 Waiver of Facilities Capital Cost of Money (Oct 1997) 3221518 ‘Reversion or Adjustment of Plans for Postretrement Benefits (PRB) Other Than Pensions 52.215-19 Noiification of Ownership Changes (Oct 1997) 3221521 ‘Requirements for Certified Cost or Pricing Data and Data Other Than Certified Cost or Pricing: Data - Modifications (Oct 2010) 52.2167 ‘Allowable Cost and Payment (Aug 2018) aa2ie8 Fixed Fee Jun 2011) 32223 Conviet Labor Gun 2003) S2220-21 Prohibition of Segregated Facilites (Apr 2015) 52.220-26 Equal Opportunity (Sep 2016) 32. Equal Opportunity for Veterans (Oct 2013) SRD Equal Opportunity Tor Workers with Disabilities Tul 3014) 32220-57 Enmployment Reports on Vaterans (Feb 2016) SL 222A Notification of Employce Rights Under the National Labor Relations Act (Dee 2010) 32223-50 Combating Trafficking ia Persons Jan 2019) 52. 54 ‘Employment Eligibility Verification (Oct 2015) [522086 Drug-Free Workplace (May 2001) 3220518 Encouraging Contractor Policies to Ban Text Messaging While Driving (Aug 2011) 52.2241 Privy Act Notification (Apr 1984) 32D Privacy Act (Apr 1984) 32208-13 Resirietions on Certain Foreign Purchases Gun 2008) S2207-1 AIT | Authorization and Consent Alfernate 1 (pr 984) 27D Notice and Assistance Regarding Patent and Copyright Iningement (Dee 2007) 32227-14 ANTV | Rights in Data ~ General Aliemate TV (Dec 2007) 323093 Federal, Stat, and Local Taxes (Feb 2013) 322302 Gost Accounting Standards (Ox 2013) 52.230-6 Administration of Cost Accounting Standards (June 2010) 32230-11 Extras (Apr 1984) S226 Progress Payments (Apr 2012) 32230 Limitation of Cost (Ape 1984) 5223 ‘Assignment of Claims (May 2014) 3223025 Prompt Payment (ian 2017) 32232.35 Payment by Electronic Funds Transfer System for Award Management (Oct 2018 52.232-39 ‘Unenforceability of Unauthorized Obligations (Jun 2013) 32232-40 Providing Accelerated Payments to Small Business Subcontractors (Dee 2013) 322501 Disputes (May 2014) Protest after Award (Aug. 1996) 322838 “Applicable Law for Breach of Contract Claim (Oct 2004) 522373 Continuity of Services Gan 1991)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 33 of 37 522423 Penalties for Unallowable Costs (May 2014) 2242-13, Bankruptey Jul 1995) 532432 ANV | Changes — Cost Reimbursement (Alt V) (Apr 1984) 52.243-7 Notification of Changes (Tan 2017) 3225 Competition in Subcontracting (Dec 1996) 32206 ‘Subcontraets for Commercial Items (Aug 2019) 32.2451 Government Property Gan 2017) 322459 Use and Charges (Apr 2012) 52.246-05, Limitation of Liability - Services (Feb 1997) S2WS “Termination for Convenience of the Government (Educational and Other Nonprofit Institutions) (Aug 2016) 322496 “Termination (Cost-Reimbursement) (May 2004) 32.249-14 “Exeusable Delays (Apr 1984) HHSAR SOURCE | TITLE AND DATE 352.203-70 ‘Anti-Lobbying (December 18, 2015) 352.208-70 Printing and Duplication (December 18, 2015) 352.2113 Paperwork Reduction Act (December 18, 2015) 352.222-70 Contractor Cooperations in Equal Employment Opportunity Investigations (December 18, 2015) SEREETO | Privacy At Deseer OTT 352.226-71 Confidential Information (December 18, 2015) 352.231-70 Salary Rate Limitation (December 18, 2015) 352.238-71 Litigation and Claims (December 18, 2015) 35223775 Key Personnel (December 18, 2013)DDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 34 of 37 Section I-2 - Clauses Incorporated In Full Text 11 - Release of Information (Jul 1999) The Contractor shall not, unless authorized in writing by the Contracting Off or interpretations concerning any plans or specifications prepared under this contract to prospective construction contractors, manufacturers, or suppliers for their use in bidding or submitting quotations on the subject project. Any cost estimates prepared by the Contractor under this contract for use either by the Government or the Contractor shall be consider privileged information and will not be divulged to any third party. (End of Clause) 1.2 CDC42.0002 Evaluation of Contractor Performance Utilizing CPARS (Apr 2015) In accordance with FAR 42.15, the Centers for Disease Control and Prevention (CDC) will review and evaluate contract performance, FAR 42.1502 and 42,1503 requires agencies to prepare evaluations of contractor performance and submit them to the Past Performance Information Retrieval System (PPIRS). The CDC utilizes the Department of Defense (DOD) web-based Contractor Performance Assessment Reporting System (CPARS) to prepare and report these contractor performance evaluations, All information contained in these assessments may be used by the Government, within the limitations of FAR 42.15, for future source selections in accordance with FAR 15.304 where past performance isan evaluation factor. ‘The CPARS system requires a contractor representative to be assigned so that the contractor has appropriate input into the performance evaluation process, The CPARS contractor representative will be given access to CPARS and. will be given the opportunity to concur or nol-concur with performance evaluations before the evaluations are complete, The CPARS contractor representative will also have the opportunity to add comments to performance evaluations. ‘The assessment is not subject to the Disputes clause of the contract, nor is it subject to appeal beyond the review and comment procedures described in the guides on the CPARS website. Refer to: www.cpars.gov for details and additional information related to CPARS, CPARS user access, how contract performance assessments are conducted, and how Contractors participate. Access and training forall persons responsible for the preparation and review of performance assessments is also available at the CPARS website The contractor must provide the CDC contracting office with the name, e-mail address, and phone number of theit designated CPARS representative who will be responsible for logging into CPARS and reviewing and commenting ‘on performance evaluations. The contractor must maintain a current representative to serve as the contractor representative in CPARS. It is the contractor's responsibility to notify the CDC contracting office, in writing (letter oor email), when their CPARS representative information needs to be changed or updated. Failure to maintain current CPARS contractor representative information will result in the loss of an opportunity to review and comment on performance evaluations. (End of Clause) 1.3 HHSAR 352.270-4b Protection of Human Subjects (December 18, 2013) (a) The Contractor agrees that the rights and welfare of human subjects involved in research under this contract shall be protected in accordance with 4S CFR part 46 and with the Contractor's current Federal-wide Assurance (FWA) on file with the Office for Human Research Protections (OHRP), Department of Health and Human Serviees. The Contractor further agrees to provide certification atleast annually thatthe Institutional Review Board has reviewedDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 35 of 37 and approved the procedures, which involve human subjects in accordance with 45 CFR part 46 and the Assurance of Complianee. (b) The Contractor shall bear full responsibility for the performance of all work and services involving the use of hhuman subjects under this contract and shall ensure that work is conducted in a proper manner and as safely as is feasible, The parties hereto agree that the Contractor retains the right to control and direct the performance of all work under this contract, Nothing in this contract shall create an agency or employee relationship between the Government and the Contractor, or any subcontractor, agent or employee of the Contractor, or any other person, organization, institution, or group of any kind whatsoever. The Contractor agrees that it has entered into this contract and will discharge its obligations, duties, and undertakings and the work pursuant thereto, whether requiring professional judgment or otherwise, as an independent Contractor without creating liability on the part of the Government for the acts of the Contractor or its employees. (6) Contractors involving other agencies or institutions in activities considered to be engaged in research involving human subjects must ensure that such other agencies or institutions obtain their own FWA if they are routinely engaged in research involving human subjects or ensure that such agencies or institutions are covered by the Contractors’ FWA via designation as agents of the institution or via individual investigator agreements (so OHRP website at: hip://www.hhs.sov/ohrp/policy/suidanceonaltemativevofwa.pdf - PDE), (@) Ifat any time during the performance of this contract the Contractor is not in compliance with any of the requirements and or standards stated in paragraphs (a) and (b) above, the Contracting Officer may immediately suspend, in whole or in part, work and further payments under this contract until the Contractor corrects the noncompliance. The Contracting Officer may communicate the notice of suspension by telephone with confirmation in writing. Ifthe Contractor fails to complete corrective action within the period of time designated in the Contracting Officer's written notice of suspension, the Contracting Officer may, afler consultation with OHRP, terminate this contract in whole or in part (End of clause) HHSAR 352.270-6 Restriction on Use of Human Subjects (December 18, 2015) 14 Pursuant to 45 CER part 46, Protection of Human Research Subjects. the Contractor shall not expend funds this award for tesearch involving human subjects or engage in any human subjects research activity prior to the Contracting Officer's receipt ofa certification thatthe research has been reviewed and approved by the Institutional Review Board (IRB) registered with OHRP. This testriction applies to all collaborating sites, whether domestic or foreign, and subcontractors, The Contractor must ensure compliance by collaborators und subeontractors. (End of clause) LS HHSAR 352.270-12 Needle Exchange (December 18, 2018) ‘The Contractor shall not use any funds obligated under this contract to carry out any program of distributing sterile needles or syringes for the hypodermic injection of any illegal drug. (End of Clause) 1.6 HHSAR 352.270-13 Continued Ban on Funding Abortion and Continued Ban on Funding of Human Embryo Research, (December 18, 2015) (a) The Contractor shall not use any funds obligated under this contract for any abortion (b) The Contractor shall not use any funds obligated under this contract for the following: (1) The creation of a human embryo or embryos for research purposes: orDDocusign Envelope ID: 2576827A-EF35-4987-8812-FOIARSFa35a8 Page 36 of 37 (2) Research in which a human embryo or embryos are destroyed, discarded, or knowingly subjected to risk of injury of death greater than that allowed for research on fetuses in utero under 45 CFR Part 46 and Section 498(b) of the Public Health Service Act (42 U.S.C. 289a(b)) (6) The term “human embryo or embryos" includes any organism, not protected as a human subject under 45 CFR Part 46 as ofthe date of the enactment ofthis Act, that is derived by fertilization, parthenogenesis, cloning, or any other means from one ot more human gametes of human diploid cells, (@) The Contractor shall not use any Federal funds for the cloning of human beings. (End of clause)DDocuSign Envelope ID: 2576827A-EF35-4367-8612-FO3A8SF83538 Page 37 of 37 Section J - List Of Attachments “There is nothing in this seetion,