75D301-19-R-67951.doc

SOLICITATION, OFFER AND AWARD

1. THIS CONTRACT IS A RATED ORDER

UNDER DPAS (15 CFR 700)

RATING

PAGE OF

2. CONTRACT NO.

3. SOLICITATION NO.

75D301-19-R-67951

4. TYPE OF SOLICITATION

X

NEGOTIATED (RFP)

5. DATE ISSUED

6. REQUISITION/PURCHASE NO.

00HCVGDB-2019-31829

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Approved as to Form and Legality: _____________________________

NOTE: In sealed bid solicitations “offer” and “offeror” mean “bid” and “bidder.”

SOLICITATION

9. Sealed offers in original and handcarried, in the depository located in 2:00pformtext until local time 7/15/19 CAUTION -- LATE Submissions, Modifications, and Withdrawals: See Section L, Provision No. 52.214-7 or 52.215-1. All offers are subject to all terms and conditions contained in this solicitation.

10. FOR INFORMATION

CALL:

A. NAME

Monica Shaw

B. TELEPHONE (NO COLLECT CALLS)

AREA CODE NUMBER: EXT:

(770) 488-8213

C. E-MAIL ADDRESS

11. TABLE OF CONTENTS

(x)

DESCRIPTION

(x)

DESCRIPTION

X

REPRESENTATIONS, CERTIFICATIONS, AND

OFFER (Must be fully completed by offeror)

NOTE: Item 12 does not apply if the solicitation includes the provisions at 52.214-16, Minimum Bid Acceptance Period.

12. In compliance with the above, the undersigned agrees, if this offer is accepted within period is inserted by the offeror) from the date for receipt of offers specified above, to furnish any or all items upon which prices are offered at the price set opposite each item, delivered at the designated point(s), within the time specified in the schedule.

13. DISCOUNT FOR PROMPT PAYMENT

(See Section I, Clause No. 52-232-8)

10 CALENDAR DAYS

20 CALENDAR DAYS

30 CALENDAR DAYS

CODE

FACILITY

16. NAME AND ADDRESS OF PERSON AUTHORIZED TO SIGN OFFER

15B. TELEPHONE NO.

AREA CODE NUMBER EXT.

15C. CHECK IF REMITTANCE ADDRESS

SUCH ADDRESS IN SCHEDULE.

17. SIGNATURE

18. OFFER DATE

AWARD (To be completed by Government)

19. ACCEPTED AS TO ITEMS NUMBERED

20. AMOUNT

22. AUTHORITY FOR USING OTHER THAN FULL AND OPEN COMPETITION:

21. ACCOUNTING AND APPROPRIATION

23. SUBMIT INVOICES TO ADDRESS SHOWN IN

(4 copies unless otherwise specified)

ITEM

Centers for Disease Control and Prevention (CDC)

Office of Acquisition Services (OAS)

2900 Woodcock Blvd, MS TCU-4

Atlanta, GA 30341-4004

Centers for Disease Control and Prevention (FMO)

PO Box 15580 404-718-8100

Atlanta, GA 30333-0080

26. NAME OF CONTRACTING OFFICER (Type or print)

27. UNITED STATES OF AMERICA

(Signature of Contracting Officer)

28. AWARD DATE

IMPORTANT -- Award will be made on this form, or on Standard Form 26, or by other authorized official written notice.

AUTHORIZED FOR LOCAL REPRODUCTION

STANDARD FORM 33 (REV. 9-97)

PREVIOUS EDITION IS UNUSABLE

Prescribed by GSA

FAR (48 CFR) 53.214©

Section B - Supplies Or Services And Prices/Costs Firm Fixed Price Contract

Base Period - 9/1/2019 – 8/31/2020 1 Job

Option Period 1 - 9/1/2020 – 8/31/2021 1 Job

Option Period 2 - 9/1/2021 – 8/31/2022 1 Job

Option Period 3 - 9/1/2022 – 8/31/2023 1 Job

Option Period 4 – 9/1/2023 – 8/31/2024 1 Job

There are no clauses/provisions included in this section.

Section C - Description/Specification/Work Statement

PERFORMANCE BASED WORK STATEMENT

Title of Project: Pre and post Influenza Human Sera Panels

C. Statement of Work

C.1 Background and Need:

Influenza is a highly contagious respiratory disease and epidemics of influenza cause substantial morbidity and mortality worldwide. The Advisory Committee on Immunization Practices (ACIP) recommends influenza vaccination for all persons > 6 months who do not have contraindications. The seasonal influenza vaccine requires frequent updates due to the constant evolution of influenza viruses resulting in antigenic drift.

As a World Health Organization Collaborating Centers (WHO CC) for Reference and Research on Influenza and a member of the Global Influenza Surveillance Network, the Centers for Disease Control and Prevention closely monitors the genetic and antigenic evolution of circulating influenza viruses. The five WHO CCs meet twice each year to recommend the virus strains composition for the upcoming season’s influenza vaccine. The meeting is held every February for the northern hemisphere influenza vaccine recommendations and every September for the southern hemisphere influenza vaccine recommendations. Epidemiological, genetic, antigenic, as well as serological data are critical in guiding vaccine recommendations.

CDC is seeking pre- and post- influenza immunization sera panels from six age cohorts, young pediatric (6 months to 35 months), older pediatric and adolescent (3-8yrs and 9-17yrs)), adult (18-49 yrs), older adult (50-64 yrs) and elderly (65 yrs+) populations to determine if antibodies induced by the current influenza vaccine effectively inhibit currently circulating influenza viruses. The ability of antibodies in post-influenza vaccine serum samples to inhibit hemagglutination or to neutralize currently circulating influenza viruses is a measure of how effective the current vaccine will be at inducing protective antibodies against circulating influenza viruses.

All sera panels will be tested by hemagglutination inhibition (HI),microneutralizaiton (MNT) assays and other immunological assays to evaluate the immune response induced by the current influenza vaccine to newly circulating viruses. HI and MNT results will also be analyzed to compare the seroconversions or four-fold rise in titers between pre- and post-vaccination sera induced by the current influenza vaccine to titer response rises demonstrated against newly circulating viruses.

In addition, CDC is seeking large volume post-influenza immunization sera from adult donors for use in hemagglutination inhibition, virus neutralization, and other relevant immunological assays for antigenic characterization of virus isolates submitted to CDC for surveillance and characterization of immune responses following influenza vaccination.

C.2 Project Objectives:

This contract is for the provision of anonymous serum samples from six age cohorts (young pediatric, older pediatric, adolescents, adult, older adults and elderly) with each individual providing blood prior to administration of the specified current, quadrivalent, seasonal, killed virus, influenza vaccine (S1) and again three to four weeks after immunization (S2). For young pediatric populations (ages 6-35 months) and older pediatrics whom require two doses of influenza vaccines, the S2 blood will be collected three to four weeks after the second dose of influenza vaccine. Serum samples will be tested for vaccine-induced antibodies in order to determine if the current influenza vaccine strains induce protective levels of antibodies against newly circulating influenza virus strains that may exhibit antigenic drift.

This contract is also for the provision of large volume S2 samples from half of the adult participants for use in hemagglutination inhibition assays with virus isolates and characterization of immune responses following influenza vaccination.

C.3 Scope of Work:

This is a five year contract (including options) for the provision of pre- and post- immunization serum samples from eligible young pediatric, older pediatric and adolescent, adult, older adult and elderly participants with the specified current, seasonal, quadrivalent, killed virus influenza vaccine. All participants each age panel should receive the same types of vaccines.

The contractor shall provide pre-and post-immunization serum samples from the below age panels:

1). 80 young pediatric participants (age 6-35 months)

The 80 pediatric participants between the ages of 6 months through 35 months must be healthy and eligible to receive the influenza vaccine for the first time. Infants and children with a prior history of vaccination or a prior history of laboratory confirmed influenza are excluded from participating. This cohort must receive the current licensed seasonal quadrivalent egg-based killed virus influenza vaccine.

2). 60 older pediatric participants (age 3-8y)

The 60 older pediatric participants between the ages of 3-8y must be healthy. Thirty (30) participants in this cohort must receive the current seasonal quadrivalent egg-based killed virus influenza vaccine and 30 participants in this cohort must receive the current licensed seasonal quadrivalent cell-based killed virus influenza vaccine.

3). 60 older pediatric/adolescent participants (age 9-17y)

The 60 older pediatric/adolescent participants between the ages of 9-17y must be healthy. Thirty (30) participants in this cohort must receive the current seasonal quadrivalent egg-based killed virus influenza vaccine and 30 participants in this cohort must receive the current licensed seasonal quadrivalent cell-based killed virus influenza vaccine.

4). 80 adult participants (age 18-49y)

Adult participants must be between the ages of 18 years through 49 years and healthy. Forty (40) participants in this cohort must receive the current seasonal quadrivalent egg-based killed virus influenza vaccine and 40 participants in this cohort must receive the current licensed seasonal quadrivalent cell-based killed virus influenza vaccine.

5). 60 older adult participants (age 50-64y)

Older adult participants must be between the ages of 50 years through 64 years and healthy. This cohort must receive the current licensed seasonal quadrivalent egg-based killed virus influenza vaccine.

6). 60 elderly participants (age 65y and older)

Elderly participants must be community dwelling, aged 65 or older and healthy. This cohort must receive the current licensed seasonal quadrivalent high-dose egg-based killed virus influenza vaccine.

In addition, anyone taking immune suppressing drugs or with a history of an immune compromising disease should be excluded from participation.

The contractor shall arrange for pre-immunization serum samples (S1) to be collected at the first visit followed by administration of the influenza vaccine.

For pediatric ages 9-17y, adult, older adult, and elderly participants, the contractor shall arrange for a post-immunization serum sample (S2) to be collected 3-4 weeks after the administration of the influenza vaccine.

For young pediatric participants ages 6-35 months, and older pediatric participants age 3-8 yrs whom require 2 doses according to recommendations of the ACIP, the contractor shall arrange for a second influenza vaccine to be given 4 weeks after the first vaccine and a post- immunization serum sample (S2) to be collected 3-4 weeks after administration of the second influenza vaccine dose.

For young pediatric participants ages 6-35 months, the contractor shall arrange for the collection of approximately 5 ml of blood at each visit so that a minimum of 2.5 ml of serum is obtained. For older pediatric and adolescent participants ages 3-17y, the contractor shall arrange for the collection of approximately 10ml of blood at each visit so that a minimum of 5 ml of serum is obtained. For older adult and elderly participants, the contractor shall arrange for the collection of approximately 20 ml of blood at each visit so that a minimum of 10 ml of serum is obtained.

For adult participants, the contractor shall arrange for the collection of approximately 100 ml of blood from the post-immunization sample (S2) from a total of 20 participants who received the egg-based vaccine and a total of 20 participants who received the cell-based vaccine. This will allow for the collection of a minimum of 50 ml of serum. For the remaining 40 adult participants, the contractor shall arrange for the collection of approximately 20 ml of blood so that a minimum of 10 ml of serum is obtained.

The minimum acceptable sera volume criterion by age category is as follows:

· Pediatric (6-35mo)= 2.5 ml

· Pediatric (3-17y)=5 ml

· Adult (18-49y)= 50 ml from 40 participants and 10 ml from remaining 40 participants

· Older adult (50-64y) = 10 ml

· Elderly (65y and older) = 10 ml

Participants in the same age panel should receive the same type of vaccines. With the increased number and types of influenza vaccines available on the market, CDC may specify the types of influenza vaccines to be used for specific age panels and specific seasons.

For each participant, the contractor shall collect information on whether the participant received the prior seasonal influenza vaccine and whether the participant received the seasonal influenza vaccine within the last 2-5 years. Contractor shall document whether the participant were enrolled in the same study in the prior season(s).

C.4.

Technical Requirements:

Independently, and not as an agent of the government, the contractor will provide all management, labor, facilities, materials (except as specified herein), supplies and equipment necessary to perform the following tasks:

a. Obtain Internal Review Board (IRB) approvals: The contractor shall prepare all required documentation, submit documentation as required, and track the IRB process and approvals for the project.

b. Order vaccine: The contractor will order sufficient quadrivalent, seasonal, inactivated, influenza vaccine specified in Section C.3 for the immunization of 80 young pediatric participants ages 6-35 months, 120 old pediatric and adolescent participants ages 3-17y, 80 adult participants, 60 older adults, and 60 elderly participants. The contractor will place an early order for the vaccine so that delivery of the vaccine is expected in September. The contractor shall inform CDC the specific vaccine that will be used for each age panel ahead of the order. CDC will specify the types of influenza vaccines to be used for specific age panels and specific seasons.

c. Enroll participants: The contractor will randomly recruit participants eligible to receive the influenza vaccine. Young pediatric participants between the ages of 6 through 35 months must be healthy, and eligible to receive influenza vaccine for the first time. Infants and children with a prior history or influenza vaccination or a prior history of laboratory confirmed influenza are excluded from participating. Older pediatric and adolescent participants between the ages of 3-17y must be healthy. Adult participants must be between the ages of 18 years through 49 years and healthy. Older adult participants must be between the ages of 50 years through 64 years and healthy. Elderly participants must be 65 years of age or older and community dwelling. Anyone taking immune suppressing drugs or with a history of immune compromising disease is excluded from participation. Recruits are to be anonymous. Adult participants donating 100 ml of S2 blood will be recruited as early in the study as possible.

d. Collect blood and administer vaccine

Pediatric participants ages 6-35 months: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to administration of the vaccine, approximately 5 ml of blood will be collected. Blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine shall be administered after the blood is collected. An appointment will be made for the infant/child to return in 4 weeks. At the second visit, the second dose of vaccine will be administered and an appointment will be made for the infant/child to return in 3 to 4 weeks. At the third visit, approximately 5 ml of blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1).

Older pediatric and adolescent participants ages 3-17y: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to the administration of the vaccine, approximately 10 ml of blood will be collected. Blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine will be administered after the blood is collected.

For those older pediatrics age 3-8 yrs, that may require a second dose of vaccine based on ACIP recommendations, an appointment will be made for the child to return in 4 weeks to receive the second dose. At the second visit, the second dose of vaccine will be administered and an appointment will be made for the infant/child to return in 3 to 4 weeks. At the third visit, approximately 10 ml of blood will be collected from each participant in a collection tube designed for the collection of serum.

For those older pediatric and adolescent aged 9-17 yrs, an appointment will be made for the participant to return in 3 to 4 weeks. At the second visit, approximately 10 ml of blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1).

Adult, older adult, and elderly participants: The contractor shall confirm eligibility for the study at the first visit to the clinic. Prior to the administration of the vaccine, approximately 20 ml of blood will be collected. Blood will be collected from each participant in a collection tube designed for the collection of serum (refer to Attachment 1). The first dose of vaccine will be administered after the blood is collected. An appointment will be made for the participant to return in 3 to 4 weeks. At the second visit, for 40 adult participants, the contractor shall collect a total of 100 ml of blood. For the remaining 40 adult participants as well as older adult and elderly participants, the contractor shall collect 20 ml of blood will be collected during their second visit.

e. Process blood samples: Collect serum specimen according to CDC influenza serology specimen collection guidelines (Attachment 1). Use serum collection tubes specified in CDC protocol. After full clotting (normally 30 min-1 hour) is achieved, clotted blood should be centrifuged as soon as possible (ideally within 2 hours), to separate the clotted blood from the serum. After centrifugation, the serum shall be moved to a clean tube and aliquoted as described in Section C.4.f below. The clotted blood may be discarded.

f. Aliquot serum: All tubes containing serum shall be kept on ice during the process of aliquoting. Serum shall be aliquoted into Sarstedt tubes, catalog # 72.694.007 (or an equivalent tube agreed to by the Contracting Officer’s Representative). Each tube shall contain approximately 1.0 ml of serum. The S1 and S2 aliquots shall be labeled with separate unique identification numbers with labels provided by CDC. Multiple labels of each unique identification number will be provided so that aliquots originating from the same collection time are labeled with the same identification number.

i. Serum from pediatric participants (6-35m): For each collection time, there should be a minimum of 2.5 ml of serum obtained from the 5 ml of blood collected. Three aliquots shall be prepared. Two tubes containing 1 ml of sera and one tube containing a minimum of 0.5 ml of sera.

ii. Serum from pediatric participants (3-17y): For each collection time, there should be a minimum of 5 ml of serum obtained from the 10 ml of blood collected. Five aliquots shall be prepared. Each tube will contain 1 ml of sera.

iii. Serum from 40 adult participants from whom 20 ml of blood were collected during the second visit: For each collection time, there should be a minimum of 10 ml of serum obtained from the 20 ml of blood collected. Ten aliquots shall be prepared. Each tube will contain 1 ml of sera.

iv. Serum from 40 adult participants from whom 100 ml of blood were collected during the second visit: A minimum of 50 ml of serum should be obtained from the 100 ml of S2 blood collected. The serum shall be aliquoted into ten 1.0 ml aliquots, and the remaining serum for each donor shall be divided equally between two 50 ml conical tubes, Falcon catalog #352098 (or an equivalent tube agreed by Contracting Officer’s Representative).

v. Serum from older adult and elderly participants: For each collection time, there should be a minimum of 10 ml of serum obtained from the 20 ml of blood collected. Ten 1.0 ml aliquots shall be prepared.

Serum samples shall be immediately stored at -20° C after aliquoting.

g. Record keeping: Information for each serum sample shall be recorded on an Excel spreadsheet provided by CDC (refer to Attachment 2)

h. Shipment of serum samples to CDC: The contractor shall arrange for four shipments of serum samples to CDC. The dates and contents of each shipment are defined in Section C.10. All shipments shall be sent via overnight carrier to ensure delivery and receipt by the CDC Contracting Officer’s Representative within 24 hours of shipment. All serum shipments shall be packed with sufficient dry ice to ensure that samples remain frozen for a minimum of 72 hours after shipment. For each shipment, the Contracting Officer’s Representative and the designated laboratory contact shall be notified of the planned shipment dates and shall be sent the tracking information as soon as it is available. The contractor shall create an inventory list (excel spreadsheet) of the contents of each box of sera samples. The inventory Excel spreadsheet must contain:

a. CSID (from labels provided by CDC)

b. CUID (from labels provided by CDC)

c. Study subject number

d. Draw (S1 or S2)

e. Volume of aliquot

f. Box name

g. Absolute location in box

h. Site

i. Cohort The inventory list (excel spreadsheet) must be emailed to the Contracting Officer’s Representative and the designated laboratory contact at the time of each shipment. A hardcopy of the excel spreadsheet shall be included with each shipment. Prior to shipment all identifying linkage must be stripped from the study spreadsheet. The contractor is required to ensure the anonymity of each participant’s serum samples. Serum samples are to be sent to:

Attention: Dr Min Levine/Ms Wendy Sessions

Centers for Disease Control and Prevention

Influenza Serology

Bldg 23, Room 8451

1600 Clifton Road, NE

Atlanta, GA 30329 Phone: /404-639-3504/404-639-3211

Email: mlevine@cdc.gov/ wsessions@cdc.gov C.5 Reporting Schedule

Monthly Progress Reports: The contractor shall submit monthly progress reports to the Contracting Officer’s Representative and the Contracting Officer by the 7th day of each month. Form, format and content of reports shall be coordinated with the Contracting Officer’s Representative. It is anticipated that the progress reports for the months of July and August will be brief, but the progress reports for September, October, November, and December shall give a full accounting of the recruitment and sample collection to date. The reports shall be cumulative for the current influenza season. Each report shall list the number of participants, based on age category, for the current influenza vaccine season. The age categories shall be subdivided to indicate the number of individuals who have provided S1 and S2 serum samples.

Annual Report: By March 1 of each year, the contractor shall submit a draft annual report to the Contracting Officer’s Representative to document work performed during each contract year. Within 15 days of receipt, the Contracting Officer’s Representative will provide review comments to the contractor to be addressed and/or incorporated into the contractor’s final annual report. Form, format, and content of reports shall be coordinated with the Contracting Officer’s Representative. In addition, the contractor will be invited to include a narrative discussion of any changes that they recommend to enhance performance of any follow-up project for similar services.

C.6 Special Considerations

Only clinics/laboratories with significant experience in performing human studies will be considered for award of this contract. Only clinics/laboratories with demonstrated access to patient populations in the pediatric, adult, and elderly age categories will be considered for award of this contract. Only clinics/laboratories that demonstrate the ability to adhere to the timelines defined in Section C.10 will be considered for award of this contract.

C.7 Government Furnished Property

CDC will provide the contractor with the labels to be used on the serum sample vials. CDC will also provide a copy of the Excel spreadsheet to be used for record keeping.

C.8 References

a. Attachment 1: Human Sera Collection Guidelines for Flu Serology

b. Attachment 2: Excel Spreadsheet for Specimen Submission with example data

C.9 Deliverables

Contract deliverables include four shipments of serum samples that together contain pre- and post-immunization samples from 400 individuals (80 pediatric ages 6-35 months, 120 pediatric ages 9-17y, 80 adult, 60 older adult, and 60 elderly, as described in sections C.3 and C.4), a completed Excel spreadsheet for sample submission, the designated Monthly Reports, and the Annual Report.

Schedule of Deliverables Base Period (9/1/2019-8/31/2019):

30 October 2019

80 @ 1 x 0.5 ml each 11 December 2019

80 @ 1 x 0.5 ml each 11 December 2019

First shipment: Due on or before November 19, 2019. This shipment shall be sent as soon as the 40 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

(2) One of the two S2 aliquots in the 50 ml tube from the adult high volume donor samples.

Second shipment: Due on or before November 26, 2019. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples.

Third shipment: Due on or before December 4, 2019. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35m)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants, and (6). Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from adult (18-49y) participants donating 20 ml blood.

Fourth shipment: Due on or before December 11, 2019. After the third shipment has been received, the remaining samples shall be sent as specified in table above.

Schedule of Deliverables Option Period 1 (9/1/2020-8/31/2021):

30 October 2020

80 @ 1 x 0.5 ml each 09 December 2020

80 @ 1 x 0.5 ml each 09 December 2020

First shipment: Due on or before November 18, 2020. This shipment shall be sent as soon as the 40 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

Second shipment: Due on or before November 24, 2020. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples.

Third shipment: Due on or before December 2, 2020. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35m)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants, and (6). Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from adult (18-49y) participants donating 20 ml blood.

Fourth shipment: Due on or before December 09, 2020. After the third shipment has been received, the remaining samples shall be sent as specified in table above.

Option Period 2 (9/1/2021-8/31/2022):

30 October 2021

80 @ 1 x 0.5 ml each 14 December 2021

80 @ 1 x 0.5 ml each 14 December 2021

First shipment: Due on or before November 17, 2021. This shipment shall be sent as soon as the 40 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

Second shipment: Due on or before November 23, 2021. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples.

Third shipment: Due on or before December 7, 2021. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35m)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants, and (6). Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from adult (18-49y) participants donating 20 ml blood.

Fourth shipment: Due on or before December 14, 2021. After the third shipment has been received, the remaining samples shall be sent as specified in table above.

Option Period 3 (9/1/2022-8/31/2023):

30 October 2022

80 @ 1 x 0.5 ml each 13 December 2022

80 @ 1 x 0.5 ml each 13 December 2022

First shipment: Due on or before November 15, 2022. This shipment shall be sent as soon as the 40 adult high volume donors S2 blood samples (i.e. 100 ml) have been collected. This first shipment shall contain: (1) Two 1.0 ml aliquots of the S1 adult samples and two 1.0 ml aliquots of the corresponding S2 adult high volume donor samples.

Second shipment: Due on or before November 22, 2022. The second shipment shall contain: (1) The remaining eight 1.0 ml aliquots of the S1 sample and the remaining eight 1.0 ml aliquots of the corresponding S2 sample from the adult high volume donors samples. (2) The remaining S2 aliquot in the 50 ml tube from the adult high volume donor samples.

Third shipment: Due on or before December 6, 2022. The third shipment shall contain: (1) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 pediatric (6-35m)samples, (2) One 1.0 ml aliquot of the S1 and one 1.0 ml aliquot of the corresponding S2 older pediatric (3-8y) samples, (3) One 1.0 ml aliquot of the S1 and one 1.0ml aliquot of the corresponding S2 older pediatric (9-17y) samples (4) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 older adult (50-64y) samples, and (5) Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from elderly(65y+) participants, and (6). Two 1.0 ml aliquots of the S1 and two 1.0 ml aliquots of the corresponding S2 serum from adult (18-49y) participants donating 20 ml blood.

Fourth shipment: Due on or before December 13, 2022. After the third shipment has been received, the remaining samples shall be sent as specified in table above.

Option Period 4 (9/1/2023-8/31/2024):

30 October 2023

80 @ 1 x 0.5 ml each 12 December 2023

80 @ 1 x 0.5 ml each 12 December 2023