NIAID DAIDS NIHAI2012138.pdf

- 1 -

SOLICITATION

SECTION A - SOLICITATION/CONTRACT FORM

1. Requisition or other Purchase Authority: Public Law 81-692, as amended

2. Request for Proposal (RFP) Number:

NIAID-DAIDS-NIHAI2012138

3. Issue Date:

June 6, 2012

4. Set Aside:

[X] No

[ ] Yes See Part IV Section L

5. Title : SIMIAN VACCINE EVALUATION UNITS (SVEUS)

6. ISSUED BY:

Office of Acquisitions Division of Extramural Activities National Institute of Allergy Infectious Diseases National Institutes of Health Department of Health and Human Services 6700B Rockledge Drive, Room 3214 MSC 7612 Bethesda, Maryland 20892-7612 If using overnight delivery, use 20817

7. SUBMIT OFFERS TO:

See Part III, Section J, "Packaging and Delivery of the Proposal," ATTACHMENT 1 of this Solicitation.

8. Proposals for furnishing the supplies and/or services in THE SCHEDULE will be received at the place specified in, and in the number of copies specified in Attachment 1, "Packaging and Delivery of the Proposal," until 3:00 pm local time on August 31, 2012. Offers will be valid for 120 days unless a different period is specified by the offeror on the Attachment entitled, "Proposal Summary and Data Record, NIH 2043.

9. This solicitation requires delivery of proposals as stated in ATTACHMENT 1, "PACKAGING AND DELIVERY OF THE PROPOSAL." If proposals are requred to be delivered to two different locations, the OFFICIAL POINT OF RECEIPT for determining TIMELY DELIVERY is the address provided for the OFFICE OF ACQUISITIONS.

IF YOUR PROPOSAL IS NOT RECEIVED BY THE CONTRACTING OFFICER OR HIS DESIGNEE

AT THE PLACE AND TIME SPECIFIED FOR THE OFFICE OF ACQUISITIONS, THEN IT WILL BE

CONSIDERED LATE AND HANDLED IN ACCORDANCE WITH SUBPARAGRAPH (c)(3) OF THE FAR CLAUSE 52.215-1, ENTITLED, "INSTRUCTION TO OFFERORS-COMPETITIVE ACQUISTION" LOCATED IN

SECTION L.1. OF THIS SOLICITATION.

10. Offeror must be registered in the Central Contractor Registry (CCR) prior to award of a contract.

http://www.ccr.gov

11. FOR INFORMATION CALL: Callie Prassinos

PHONE: 301-496-0611

e-MAIL: prassinosca@niaid.nih.gov

COLLECT CALLS WILL NOT BE ACCEPTED.

Michelle L. Scala Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases http://www.ccr.gov mailto:prassinosca@niaid.nih.gov

RFP Number : NIAID-DAIDS-NIHAI2012138

- 2 -

RFP TABLE OF CONTENTS

PART I - THE SCHEDULE

SECTION A - SOLICITATION/CONTRACT FORM

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

SECTION D - PACKAGING, MARKING AND SHIPPING

SECTION E - INSPECTION AND ACCEPTANCE

SECTION F - DELIVERIES OR PERFORMANCE

SECTION G - CONTRACT ADMINISTRATION DATA

SECTION H - SPECIAL CONTRACT REQUIREMENTS

PART II - CONTRACT CLAUSES

PART III - LIST OF DOCUMENTS, EXHIBITS AND OTHER ATTACHMENTS

SECTION J - LIST OF ATTACHMENTS

SOLICITATION ATTACHMENTS

TECHNICAL PROPOSAL ATTACHMENTS

BUSINESS PROPOSAL ATTACHMENTS

INFORMATIONAL ATTACHMENTS

PART IV - REPRESENTATIONS AND INSTRUCTIONS

SECTION K - REPRESENTATIONS, CERTIFICATIONS AND OTHER STATEMENTS OF OFFERORS

SECTION L - INSTRUCTIONS, CONDITIONS, AND NOTICES TO OFFERORS

1. GENERAL INFORMATION

a. INSTRUCTIONS TO OFFERORS--COMPETITIVE ACQUISITION

b. NAICS CODE AND SIZE STANDARD

c. TYPE OF CONTRACT AND NUMBER OF AWARDS

d. TASK ORDERS UNDER MULTIPLE AWARD INDEFINITE DELIVERY CONTRACTS

e. COMMITMENT OF PUBLIC FUNDS

f. PROMOTING EFFICIENT SPENDING

g. COMMUNICATIONS PRIOR TO CONTRACT AWARD

h. RELEASE OF INFORMATION

i. PREPARATION COSTS

j. SERVICE OF PROTEST

2. INSTRUCTIONS TO OFFERORS

GENERAL INSTRUCTIONS

1. Contract Type and General Clauses

2. Authorized Official and Submission of Proposal

3. Proposal Summary and Data Record (NIH-2043)

4. Separation of Technical and Business Proposals

5. Alternate Proposals

6. Evaluation of Proposals

7. Potential Award Without Discussions

8. Use of the Metric System of Measurement

9. Privacy Act - Treatment of Proposal Information

10. Selection of Offerors

- 3 -

11. Institutional Responsibility Regarding Investigator Conflicts of Interest

12. Past Performance Information

13. Solicitation Provisions Incorporated by Reference

TECHNICAL PROPOSAL INSTRUCTIONS

1. Technical Discussions

2. Other Considerations

3. Technical Evaluation

4. Care of Live Vertebrate Animals

5. Research Involving Live Vertebrate Animals

6. Obtaining and Disseminating Biomedical Research Resources

7. Information and Physical Access Security

BUSINESS PROPOSAL INSTRUCTIONS

1. Basic Cost/Price Information

2. Proposal Cover Sheet

3. Information Other than Cost or Pricing Data

4. Requirements for Cost or Pricing Data or Information Other than Cost and Pricing Data

5. Salary Rate Limitation

6. Small Business Subcontracting Plan

7. Mentor Protege Program, HHSAR 352.219-70

8. HUBZone Small Business Concerns

9. Extent of Small Disadvantaged Business Participation

10. Total Compensation Plan

11. Other Administrative Data

12. Qualifications of the Offeror

13. Subcontractors

14. Proposer's Annual Financial Report

15. Travel Costs/Travel Policy

SECTION M - EVALUATION FACTORS FOR AWARD

1. GENERAL

2. COST/PRICE EVALUATION

3. LIVE VERTEBRATE ANIMALS EVALUATION

4. EVALUATION OF OPTIONS

5. EVALUATION OF DATA SHARING PLAN

6. TECHNICAL EVALUATION CRITERIA

7. PAST PERFORMANCE FACTOR

8. EXTENT OF SMALL DISADVANTAGED BUSINESS PARTICIPATION

- 4 -

PART I - THE SCHEDULE

THE INFORMATION SET FORTH IN SECTION A - SOLICITATION/CONTRACT FORM, HEREIN CONTAINS IMPORTANT INFORMATION FOR ANY OFFEROR INTERESTED IN RESPONDING TO THIS SOLICITATION.

ANY CONTRACT RESULTING FROM THIS SOLICITATION WILL INCLUDE IN ITS SECTION A - SOLICITATION/ CONTRACT FORM, ACCOUNTING, APPROPRIATION AND GENERAL INFORMATION APPLICABLE TO THE

CONTRACT AWARD.

THE CONTRACT SCHEDULE SET FORTH IN SECTIONS B THROUGH H, HEREIN, CONTAINS CONTRACTUAL INFORMATION PERTINENT TO THIS SOLICITATION. IT IS NOT AN EXACT REPRESENTATION OF THE CONTRACT DOCUMENT THAT WILL BE AWARDED AS A RESULT OF THIS SOLICITATION. THE CONTRACT COST OR PRICE AND OTHER CONTRACTUAL PROVISIONS PERTINENT TO THE OFFEROR (i.e., those relating to the organizational structure [e.g., Non-Profit, Commercial] and specific cost authorizations unique to the Offeror's proposal and requiring Contracting Officer Prior Approval) WILL BE DISCUSSED IN THE NEGOTIATION PROCESS AND WILL BE INCLUDED IN THE RESULTANT CONTRACT. THE ENCLOSED CONTRACT SCHEDULE IS

INTENDED TO PROVIDE THE OFFEROR WITH THE NECESSARY INFORMATION TO UNDERSTAND THE

TERMS AND CONDITIONS OF THE RESULTANT CONTRACT.

SECTION B - SUPPLIES OR SERVICES AND PRICES/COSTS

ARTICLE B.1. BRIEF DESCRIPTION OF SUPPLIES OR SERVICES

The Simian Vaccine Evaluation Unit (SVEU) program is intended to facilitate the identification of promising candidate AIDS vaccines by evaluating the immunogenicity and efficacy of candidate vaccines in nonhuman primates. Its objective is to provide information that will lead to the development of a human vaccine that can provide broadly reactive and long-lasting protective immunity against HIV infection. The Contractor shall provide support to maintain and acquire nonhuman primates, and scientific and technical expertise necessary to conduct studies in nonhuman primates.

ARTICLE B.2. PRICES/COSTS

a. This is a Multiple Award Indefinite Quantity contract as contemplated by FAR 16.504. The Government agrees to purchase not less than $100,000 (minimum) nor more than a total of $80,426,435 (maximum) for successful performance of this contract.

b. The costs set forth in this ARTICLE will cover the contract period May 1, 2013 through April 30, 2020.

c. The Government will compete and award Task Orders based on the work described in SECTION C of this contract.

d. Ordering procedures are described in The TASK ORDER PROCEDURE Article in SECTION G of this contract.

ARTICLE B.3. PROVISIONS APPLICABLE TO DIRECT COSTS

This article will prohibit or restrict the use of contract funds, unless otherwise approved by the Contracting Officer. The following is a list of items that may be included in the resultant contract as applicable. 1) Conferences & Meetings, 2) Food for Meals, Light Refreshments & Beverages, 3) Promotional Items, 4) Acquisition, by purchase or lease, of any interest in real property; 5) Special rearrangement or alteration of facilities; 6) Purchase or lease of any item of general purpose office furniture or office equipment regardless of dollar value; 7) Travel Costs including Foreign Travel; 8) Consultant Costs; 9) Subcontract Costs; 10) Patient Care Costs; 11) Accountable Government Property; 12) Printing costs; and 13) Research Funding.

- 5 -

ARTICLE B.4. ADVANCE UNDERSTANDINGS

Specific elements of cost, which normally require prior written approval of the Contracting Officer before incurrence of the cost (e.g., foreign travel, consultant fees, subcontracts) will be included in this Article if the Contracting Officer has granted his/her approval prior to contract award.

The following Advanced Understandings are applicable to this acquisition and will be included in any resultant contract award:

1. Intellectual Property

The goal of this contract is to promote the development of critical biological materials and information by producing and in part evaluating various materials for anti-HIV immunogenicity (vaccine activity). For the purposes of this agreement, "material" includes compositions of matter, and associated information such as methods of making or using the compositions. It is expected that the great majority of materials will be proprietary, in part, to third parties.

It is clear from the NIAID's experience that third party providers ("Provider") will not provide their proprietary material ("Material") without assurance that the intellectual property rights associated with their Materials will be protected.

Accordingly, to encourage Providers to provide their Materials for production or evaluation under this contract the Contractor agrees to this Article, which requires the Contractor and its subcontractors to provide a research use license and a commercialization license option to Subject Inventions made under the contract to the Providers as follows:

The Contractor agrees to promptly notify the NIAID and the Provider in writing of any Subject Inventions of the Contractor, its principal investigator and/or any other employees or agents of the Contractor, whether patentable or not, which are conceived and/or first actually reduced to practice in the performance of work under this contract using a Provider's Material (hereinafter "Contractor Invention"). The notice shall inform the Provider(s) of its right to the option set forth herein. This may be accomplished by attaching a copy of this Article to the notice.

(a) Single Provider

With respect to Contractor Inventions resulting from the use of Material provided by one Provider, the Contractor agrees to grant to the Provider: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and (ii) a time-limited first option to negotiate an exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to any Contractor Invention on terms to be negotiated in good faith by the Provider and the Contractor, subject to the following conditions:

The Contractor will allow Provider three (3) months from the date the Contractor sends written notice to the Provider of the existence of a Contractor Invention (or such additional period as the Provider and the Contractor may agree) to notify the Contractor in writing, whether or not it wants to obtain an exclusive license to the Contractor Invention.

If the Provider fails to notify the Contractor, in a timely fashion then the Contractor's obligation to offer Provider a license option with respect to that Contractor Invention will expire, and the Contractor will be free to dispose of its interests in such Contractor Invention in accordance with the Contractor's policies. If the Contractor and the Provider fail to reach agreement within ninety (90) days, (or such additional period as the Provider and the Contractor may agree) on the terms for an exclusive license for a particular Contractor Invention, then for a period of six (6) months thereafter the Contractor will not offer to license that Contractor Invention to any third party on materially better terms than those last offered to the Provider without first offering such terms to the Provider, in which case the Contractor will offer the Provider a period of thirty (30) days in which the Provider can accept or reject the offer.

(b) Multiple Providers

With respect to a Contractor Invention resulting from the use of Materials provided by multiple Providers, but which is an improvement only to a Material of a specific Provider, the Contractor agrees to grant to that Provider the rights described above in (a).

With respect to any Contractor Inventions resulting from the use of Material from multiple Providers, but that are not improvements to or specific to a single Material, the Contractor agrees to grant to each Provider who provided

- 6 -

Material: (i) a paid-up nonexclusive, nontransferable, royalty-free, world-wide license to all Contractor Inventions for research purposes only; and (ii) a time-limited first option to negotiate a co-exclusive, world-wide royalty-bearing license for all commercial purposes, including the right to grant sub-licenses, to all such Contractor Inventions on terms to be negotiated in good faith by each Provider and the Contractor subject to the following conditions:

The Contractor will allow each Provider three (3) months from the time the Provider is sent written notice by the Contractor of the existence of a Contractor Invention (or such additional period as each Provider and the Contractor may agree) to notify the Contractor, in writing, whether or not the Provider wants to obtain a co-exclusive license to the Contractor Invention. If a Provider fails to notify the Contractor, in a timely fashion then Contractor's obligation to offer that Provider a license option with respect to that Contractor Invention will expire and the Contractor will continue to offer an option to a co-exclusive license to the other Providers as set forth herein. If there is a single other Provider, it shall be offered an option to an exclusive license as though it were a single Provider. If no Provider notifies the Contractor in a timely fashion the Contractor will be free to dispose of its interests in such Contractor Invention in accordance with the Contractor's policies.

Provider Inventions

The Contractor agrees that notwithstanding anything herein to the contrary, any invention or discovery, whether patentable or not, which is not a Subject Invention as defined in 35 USC 201(e) 1 but arises out of an intentional and unauthorized use or modification of the Provider's Material by the Contractor and/or any other employees or agents of the Contractor, will be the property of the Provider (hereinafter "Provider Invention"). The Contractor will promptly notify the Provider in writing of any such Provider Inventions and, at the Provider's request and expense, the Contractor will take such further action as necessary to ensure that the Provider shall have all right, title and interest in and to any such Provider Inventions and give Provider any assistance reasonably necessary to obtain patents (including causing the execution of any invention assignment or other documents). The NIAID recognizes that the Contractor may also be conducting other research using the Provider's Material under the authority of a separate agreement with the Provider during the term of this contract; any invention arising under such separate agreement will not be subject to the terms of this provision entitled, "Provider Inventions."

Protection of Proprietary Data

All Materials, data and other information supplied by the Provider or the Project Officer shall be assumed to be confidential unless specifically identified as not confidential in writing by the Project Officer. The Contractor agrees that its principal investigator and/or any other employees or agents of the Contractor will provide the data generated under this contract exclusively to the NIAID or if directed by the NIAID, to the Provider and the FDA or other appropriate Federal agency. The Contractor understands that the NIAID may need to negotiate individual agreements with the various Providers to obtain Materials and that the terms of the agreements may vary. The NIAID intends that these agreements will provide for the Contractor's right to publish results generated by the Contractor under this contract after a reasonable period of time to allow the Provider to file patent applications and to protect its proprietary information. The Contractor agrees to enter into material transfer agreements with Providers when required by the Providers as a condition for the Contractor to receive Materials. Such agreements shall reference this contract by contract number and shall be consistent with any agreement the NIAID has entered into with the Provider to obtain Materials. In the event the Contractor reasonably objects to the terms of the material transfer agreement, the Contractor shall promptly bring such objection to the attention of the Contracting Officer for an appropriate resolution.

135 USC 201(e): The term ''subject invention'' means any invention of the contractor conceived or first actually reduced to practice in the performance of work under a funding agreement: Provided, That in the case of a variety of plant, the date of determination (as defined in section 41(d) of the Plant Variety Protection Act (7 U.S.C. 2401(d)) must also occur during the period of contract performance.

2. Invoices - Cost and Personnel Reporting, and Variances from the Negotiated Budget

a. The Contractor agrees to provide a detailed breakdown on invoices of the following cost categories:

1) Direct Labor - List individuals by name, title/position, hourly/annual rate, level of effort, and amount claimed.

- 7 -

2) Fringe Benefits - Cite rate and amount

3) Overhead - Cite rate and amount

4) Materials & Supplies - Include detailed breakdown when total amount is over $1,000.

5) Travel - Identify travelers, dates, destination, purpose of trip, and amount. Cite COA, if appropriate. List separately, domestic travel, general scientific meeting travel, and foreign travel.

6) Consultant Fees - Identify individuals and amounts.

7) Subcontracts - Attach subcontractor invoice(s).

8) Equipment - Cite authorization and amount.

9) G&A - Cite rate and amount.

10) Total Cost

11) Fixed Fee

12) Total CPFF

Monthly invoices must include the cumulative total expenses to date, adjusted (as applicable) to show any amounts suspended by the Government.

b. The Contractor agrees to immediately notify the Contracting Officer in writing if there is an anticipated overrun (any amount) or unexpended balance (greater than 10 percent) of the amount allotted to the contract, and the reasons for the variance. Also refer to the requirements of the Limitation of Funds and Limitation of Cost Clauses in the contract.

3. Advance Copies of Press Releases

The Contractor agrees to accurately and factually represent the work conducted under this contract in all press releases. In accordance with NIH Manual Chapter 1754, misrepresenting contract results or releasing information that is injurious to the integrity of NIH may be construed as improper conduct. The complete text of NIH Manual Chapter 1754 can be found at: http://www1.od.nih.gov/oma/manualchapters/management/1754/

Press releases shall be considered to include the public release of information to any medium, excluding peer-reviewed scientific publications. The contractor shall ensure that the Contracting Officer's Representative (COR) has received an advance copy of any press release related to this contract not less than four (4) working days prior to the issuance of the press release.

- 8 -

SECTION C - DESCRIPTION/SPECIFICATIONS/WORK STATEMENT

ARTICLE C.1. STATEMENT OF WORK

a. Independently and not as an agent of the Government, the Contractor shall be required to furnish all the necessary services, qualified personnel, material, equipment, and facilities, not otherwise provided by the Government, as needed to perform the Statement of Work, dated April 24, 2012, attached hereto and made a part of this Solicitation (See SECTION J - List of Attachments).

ARTICLE C.2. REPORTING REQUIREMENTS

All reports required herein shall be submitted in electronic format. In addition, one hardcopy of each report shall be submitted to the Contracting Officer.

All electronic reports submitted shall be compliant with Section 508 of the Rehabilitation Act of 1973. Additional information about testing documents for Section 508 compliance, including specific checklists, by application, can be found at: http://www.hhs.gov/web/508/index.html under "Helpful Resources."

All paper/hardcopy documents/reports submitted under this contract shall be printed or copied, double-sided, on at least 30 percent post consumer fiber paper, whenever practicable, in accordance with FAR 4.302(b).

a. Technical Progress Reports

1. In addition to the required reports set forth elsewhere in this Schedule, the preparation and submission of regularly recurring Technical Progress Reports will be required in any Task Orders resulting from this solicitation. These reports will require descriptive information about the activities undertaken during the reporting period and will require information about planned activities for future reporting periods. The frequency and specific content of these reports will be determined prior to Task Order award. [Note: Beginning May 25, 2008, the Contractor shall include the applicable PubMed Central or NIH Manuscript Submission reference number when citing publications that arise from its NIH funded research.]

For proposal preparation purposes only, it is estimated that in addition to the required electronic version(s) one hard copy of these reports will be required for Task Orders as follows:

[X] Monthly Census Reports (Task Area 1) [X] Annual Progress Reports (Task Area 1) [X] Draft Study Report (Task Area 3) [X] Final Study Report (Task Area 3) [X] Final Report (Task Area 1)

b. Other Reports/Deliverables

1. Information Security and Physical Access Reporting Requirements

The Contractor shall submit the following reports as required by the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of the Task Order. Note: Each report listed below includes a reference to the appropriate subparagraph of this Article.

http://www.hhs.gov/web/508/index.html

- 9 -

a. Roster of Employees Requiring Suitability Investigations

The Contractor shall submit a roster, by name, position, e-mail address, phone number and responsibility, of all staff (including subcontractor staff) working under the contract who will develop, have the ability to access, or host and/or maintain a Federal information system(s). The roster shall be submitted to the Contracting Officer's Representative (COR), with a copy to the Contracting Officer, within 14 calendar days of the effective date of the contract. (Reference subparagraph A.e. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

b. IT Security Plan (IT-SP) In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-SP within thirty

(30) days after contract award. The IT-SP shall be consistent with, and further detail the approach to, IT security contained in the Contractor's bid or proposal that resulted in the award of this contract. The IT-SP shall describe the processes and procedures that the Contractor will follow to ensure appropriate security of IT resources that are developed, processed, or used under this contract. If the IT-SP only applies to a portion of the contract, the Contractor shall specify those parts of the contract to which the IT-SP applies.

The Contractor shall review and update the IT-SP in accordance with NIST SP 800-53A, Guide for Assessing the Security Controls in Federal Information Systems and Organizations, on an annual basis.

(Reference subparagraph D.c.1. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

c. IT Risk Assessment (IT-RA)

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the contractor shall submit the IT-RA within thirty

(30) days after contract award. The IT-RA shall be consistent, in form and content, with NIST SP 800-30, Risk Management Guide for Information Technology Systems, and any additions or augmentations described in the HHS-OCIO Information Systems Security and Privacy Policy. The Contractor shall update the IT-RA on an annual basis.

(Reference subparagraph D.c.2. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

d. FIPS 199 Assessment

In accordance with HHSAR Clause 352.239-72, Security Requirements For Federal Information Technology Resources, the Contractor shall submit a FIPS 199 Assessment within thirty (30) days after contract award. The FIPS 199 Assessment shall be consistent with the cited NIST standard.

(Reference subparagraph D.c.3. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECITON H of this contract).

e. Reporting of New and Departing Employees

The Contractor shall notify the Contracting Officer's Representative (COR) and Contracting Officer within five working days of staffing changes for positions that require suitability determinations as follows:

- 10 -

a. New Employees who have or will have access to HHS Information systems or data: Provide the name, position title, e-mail address, and phone number of the new employee. Provide the name, position title and suitability level held by the former incumbent. If the employee is filling a new position, provide a description of the position and the Government will determine the appropriate security level.

b. Departing Employees: 1) Provide the name, position title, and security clearance level held by or pending for the individual; and 2) Perform and document the actions identified in the "Employee Separation Checklist", attached in Section J, ATTACHMENTS of this contract, when a Contractor/Subcontractor employee terminates work under this contract. All documentation shall be made available to the COR and/or Contracting Officer upon request.

(Reference subparagraph E.2.a-c. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

f. Contractor - Employee Non-Disclosure Agreement(s)

The Contractor shall complete and submit a signed and witnessed "Commitment to Protect Non-Public Information - Contractor Agreement" form for each contractor and subcontractor employee who may have access to non-public Department information under this contract. This form is located at: http://ocio.nih.gov/docs/public/ Nondisclosure.pdf.

(Reference subparagraph E.3.d. of the INFORMATION AND PHYSICAL ACCESS SECURITY Article in SECTION H of this contract.)

ARTICLE C.3. INVENTION REPORTING REQUIREMENT

All reports and documentation required by FAR Clause 52.227-11, Patent Rights-Ownership by the Contractor including, but not limited to, the invention disclosure report, the confirmatory license, and the Government support certification, shall be directed to the Division of Extramural Inventions and Technology Resources (DEITR), OPERA, OER, NIH, 6705 Rockledge Drive, Suite 310, MSC 7980, Bethesda, Maryland 20892-7980 (Telephone: 301-435-1986). In addition, one copy of an annual utilization report, and a copy of the final invention statement, shall be submitted to the Contracting Officer. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted to the Contracting Officer on the expiration date of the contract.

The first annual utilization report shall be due on or before May 31, 2014. Thereafter, reports shall be due on or before the 30th Calendar day following the reporting period. The final invention statement (see FAR 27.303(b)(2)(ii)) shall be submitted on the expiration date of the contract. All reports shall be sent to the following address:

Contracting Officer Office of Acquisitions, DEA National Institute of Allergy and Infectious Diseases National Institutes of Health Department of Health and Human Services 6700B Rockledge Drive, MSC 7612, Room 3214 Bethesda, Maryland 20892- 7612

If no invention is disclosed or no activity has occurred on a previously disclosed invention during the applicable reporting period, a negative report shall be submitted to the Contracting Officer at the address listed above.

To assist contractors in complying with invention reporting requirements of the clause, the NIH has developed "Interagency Edison," an electronic invention reporting system. Use of Interagency Edison is encouraged as it streamlines the reporting process and greatly reduces paperwork. Access to the system is through a secure http://ocio.nih.gov/docs/public/Nondisclosure.pdf

- 11 -interactive Web site to ensure that all information submitted is protected. Interagency Edison and information relating to the capabilities of the system can be obtained from the Web ( http://www.iedison.gov), or by contacting the Extramural Inventions and Technology Resources Branch, OPERA, NIH.

http://www.iedison.gov

- 12 -

SECTION D - PACKAGING, MARKING AND SHIPPING

All deliverables required under this contract shall be packaged, marked and shipped in accordance with Government specifications. At a minimum, all deliverables shall be marked with the contract number and Contractor name. The Contractor shall guarantee that all required materials shall be delivered in immediate usable and acceptable condition.

- 13 -

SECTION E - INSPECTION AND ACCEPTANCE

a. The Contracting Officer or the duly authorized representative will perform inspection and acceptance of materials and services to be provided.

b. For the purpose of this SECTION, Contracting Officer's Representative is the authorized representative of the Contracting Officer.

c. Inspection and acceptance will be performed at:

Vaccine Research Program Division of AIDS National Institute of Allergy and Infectious Diseases, NIH Department of Health and Human Services 6700B Rockledge Drive Bethesda, MD 20892

Acceptance may be presumed unless otherwise indicated in writing by the Contracting Officer or the duly authorized representative within 30 days of receipt.

d. This contract incorporates the following clause by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available.

FAR Clause 52.246-8, Inspection of Research and Development - Cost-Reimbursement (May 2001).

- 14 -

SECTION F - DELIVERIES OR PERFORMANCE

ARTICLE F.1. PERIOD OF PERFORMANCE

The ordering period of this contract shall be from May 1, 2013 through April 30, 2020.

ARTICLE F.2. CLAUSES INCORPORATED BY REFERENCE, FAR 52.252-2 (FEBRUARY 1998)

This contract incorporates the following clause(s) by reference, with the same force and effect as if it were given in full text. Upon request, the Contracting Officer will make its full text available. Also, the full text of a clause may be accessed electronically at this address: http://www.acquisition.gov/comp/far/index.html

FEDERAL ACQUISITION REGULATION (48 CFR CHAPTER 1) CLAUSE:

52.242-15, Stop Work Order (August 1989) with Alternate I (April 1984).

http://www.acquisition.gov/comp/far/index.html

- 15 -

SECTION G - CONTRACT ADMINISTRATION DATA

ARTICLE G.1. CONTRACTING OFFICER'S REPRESENTATIVE (COR)

The following Contracting Officer's Representative (COR) will represent the Government for the purpose of this contract:

To be named at time of award.

The COR is responsible for: (1) monitoring the Contractor's technical progress, including the surveillance and assessment of performance and recommending to the Contracting Officer changes in requirements; (2) interpreting the statement of work and any other technical performance requirements; (3) performing technical evaluation as required; (4) performing technical inspections and acceptances required by this contract; and (5) assisting in the resolution of technical problems encountered during performance.

The Contracting Officer is the only person with authority to act as agent of the Government under this contract. Only the Contracting Officer has authority to: (1) direct or negotiate any changes in the statement of work; (2) modify or extend the period of performance; (3) change the delivery schedule; (4) authorize reimbursement to the Contractor for any costs incurred during the performance of this contract; or (5) otherwise change any terms and conditions of this contract.

The Government may unilaterally change its COR designation.

ARTICLE G.2. KEY PERSONNEL, HHSAR 352.242-70 (January 2006)

The key personnel specified in this contract are considered to be essential to work performance. At least 30 days prior to diverting any of the specified individuals to other programs or contracts (or as soon as possible, if an individual must be replaced, for example, as a result of leaving the employ of the Contractor), the Contractor shall notify the Contracting Officer and shall submit comprehensive justification for the diversion or replacement request (including proposed substitutions for key personnel) to permit evaluation by the Government of the impact on performance under this contract. The Contractor shall not divert or otherwise replace any key personnel without the written consent of the Contracting Officer. The Government may modify the contract to add or delete key personnel at the request of the Contractor or Government.

(End of Clause)

The following individual(s) is/are considered to be essential to the work being performed hereunder:

Name Title

ARTICLE G.3. TASK ORDER PROCEDURE

This contract provides for the issuance of Task Orders on a negotiated basis as follows:

a. General Only the Contracting Officer may issue Task Orders to the Contractor, providing specific authorization or direction to perform work within the scope of the contract and as specified in the Statement of Work. Unless specifically authorized by the Contracting Officer, the Contractor shall not commence work until a fully executed Task Order has been awarded. The Contractor may incur costs under this contract in performance of task orders and task order modifications issued in accordance with this ARTICLE.

No other costs are authorized unless otherwise specified in the contract or expressly authorized by the Contracting Officer.

- 16 -

b. Requesting Task Order Proposals.

The Contracting Officer or a designated individual may solicit responses to requirements from Contractors within a technical area covered by a task order requirement in writing. A Task Order Request for Proposals (TORFP) will be prepared and issued for each task order requirement.

Generally, the Task Order Request for Proposal (TORFP) will include but is not limited to the following:

1. Statement of Work;

2. Reporting Requirements and Deliverables;

3. Proposal Due Date and Location to Deliver Proposals;

4. Period of Performance of Task Order;

5. Anticipated type of Task Order;

6. Technical Proposal Instructions;

7. Business proposal Instructions

8. Evaluation Factors for Award

All contract clauses contained this contract shall be incorporated in the TORFP and the resultant task order.

If conflicts exist between the contract clauses and the information outlined in the task order, the contract language takes precedence over the information in the task order.

Contractors are not required to propose on all TORFPs. Those eligible Contractors that decide not to submit a proposal shall advise the Contracting Officer, in writing, of their intention not to submit a proposal on or before the closing date and time established in the TORFP. An election not to propose on a given TORFP will not negatively affect or prohibit a Contractor from competing on future TORFPs. However, it may affect the Contractor's eligibility for continuations or extensions of the resultant Task Order.

c. Competitive Ordering Process.

1. All Contractors within a technical area will receive e-mail notification advising of the availability of each proposed task order requirement. All proposed task orders will incorporate all terms of this contract unless otherwise specified in the proposed task order.

2. Contractors will be provided an adequate time to prepare and submit responses based on the Contracting Officer's consideration of the estimated dollar value and complexity of proposed task order. Responses will not be considered a proposal as defined in FAR Part 15. However, the Contractor shall provide information sufficient for consideration in accordance with FAR Part 16. Each TORFP will indicate the criteria for the evaluation of proposals. The responses shall demonstrate capability for each criterion to be evaluated.

Generally, the Contractor will be asked to demonstrate the following as appropriate:

• Understanding of the requirements;

• Experience and capability on similar tasks;

• Technical approach, methods and procedures for satisfying the requirements with a discussion of potential problems to be encountered and proposed solutions and/or risk mitigation strategies.

• Procedures for assuring quality of work, products, and deliverables;

• Plan for managing the task order, including meeting requirements and schedules, and performance measures (if applicable);

• Staffing plan with skill levels and level of effort for each individual proposed. Generally, resumes will be required for proposed personnel (if not previously submitted);

• References to evaluate past performance; and

- 17 -

• Cost/Price to perform the task order.

d. Evaluation and Award of Task Order Proposals

The Government will evaluate the Task Order proposals against the requirements of the TORFP.

Specifically, the technical evaluation factors, cost/price, past performance and any other factor specifically identified in the TORFP will be used for evaluation of each proposal. In addition, the TORFP will identify the basis for selecting a contractor for award. Generally, technical factors will be significantly more important than cost or price However, each TORFP will specify how the award decision will be made.

Upon completion of evaluations, the Contracting Officer will issue a task order to the Contractor whose proposal is most advantageous to the government

The Contracting Officer will notify the Contractor(s) of the selection decision in writing.

e. Fair Opportunity

1. In accordance with FAR 16.505(b)(1)(i), each awardee will be given a fair opportunity to be considered for each order issued over $3,000 unless the following exception(s) apply:

(i) The agency need for the supplies or services is so urgent that providing a fair opportunity would result in unacceptable delays.

(ii) Only one awardee is capable of providing the supplies or services required at the level of quality required because the supplies or services ordered are unique or highly specialized.

(iii) The order must be issued on a sole-source basis in the interest of economy and efficiency because it is a logical follow-on to an order already issued under the contract, provided that all awardees were given a fair opportunity to be considered for the original order.

(iv) It is necessary to place an order to satisfy a minimum guarantee.

2. All awardees will be given a fair opportunity to be considered in accordance with the FAR as follows:

(i) For orders exceeding $3,000 up to the simplified acquisition threshold, in accordance with FAR 16.505(b)(1)(ii);

(ii) For orders exceeding the simplified acquisition threshold up to $5 Million, in accordance with 16.505(b) (1)(iii); and,

(iii) For orders exceeding $5 Million, in accordance with FAR 16.505(b)(1)(iv).

ARTICLE G.4. RECIPIENTS REIMBURSEMENT PROCEDURES

a. During the course of this contract, the Contracting Officer or his duly designated representative will notify the Contractor to make certain shipments of nonhuman primates directly to specified U.S. Government Recipients, Contractors, Government Agencies, or other private organizations and the Contractor shall make such shipments as directed.

b. The Contractor shall bill recipients directly for the nonhuman primates provided. The charges for these nonhuman primates shall be based upon the current NIAID price list for the items listed in an Attachment in SECTION J, of this contract. Under no circumstances shall the Contractor bill prices other than those listed in the referenced price list. Prices listed are subject to change. Revised price lists will be issued by the Government when appropriate without the concurrence of the Contractor.

c. The Contractor shall keep an accurate account of all payments received from recipients separate from other fiscal aspects of the contract. The Contractor shall record as credits on monthly invoices to the Government, all payments received from the Government Grantees, Contractors, Government Agencies, or other private

- 18 -organizations. The income from recipients must be credited to the Government in the billing period actually received. Thus, the Contractor shall bill the Government directly for payment of contract costs and shall subtract as a credit all payments received from recipients. The actual collections from sales shall be offset against the gross billing, leaving a net amount due on the invoice.

The Contracting Officer's Representative (COR) may direct from time to time that shipments be made entirely at Government expense.

d. The Contractor shall account for the contract related income separately in accordance with its own double entry accounting system. The Contractor shall submit to the Government a Monthly Summary Sheet of Sales, which is listed as an Attachment in SECTION J of this contract. The Contractor shall submit a copy of this Attachment each month with the Monthly Progress Report.

The administration of the contract related income shall be subject to the terms of this contract, including specifically and without limitation, FAR Clause 52.215-2, Audit and Records--Negotiation, of the General Clauses (including applicable Alternates), and the applicable cost principles of the Federal Acquisition Regulation.

e. The Contractor shall use the following procedures for collection of delinquent accounts:

Step 1 - Accounts 30 days past due. A copy of the invoice shall be sent to the recipient with a notation that the account is overdue and request payment.

Step 2 - Accounts 60 days past due. The Contractor shall turn the account over to a collection agency.

f. When the completion (final) invoice is submitted on this contract, a listing of all outstanding recipient invoices shall be provided along with details as to what disposition is expected on each.

ARTICLE G.5. INVOICE SUBMISSION/CONTRACT FINANCING REQUEST AND CONTRACT

FINANCIAL REPORT

a. Invoice/Financing Request Instructions and Contract Financial Reporting for NIH Cost-Reimbursement Type Contracts NIH(RC)-4 are attached and made part of this contract. The Contractor shall follow the attached instructions and submission procedures specified below to meet the requirements of a "proper invoice" pursuant to FAR Subpart 32.9, Prompt Payment.

1. Payment requests shall be submitted to the offices identified below. Do not submit supporting documentation (e.g., receipts, time sheets, vendor invoices, etc.) with your payment request unless specified elsewhere in the contract or requested by the Contracting Officer.

a. The original invoice shall be submitted to the following designated billing office:

National Institutes of Health Office of Financial Management Commercial Accounts 2115 East Jefferson Street, Room 4B-432, MSC 8500 Bethesda, MD 20892-8500

b. One copy of the invoice shall be submitted to the following approving official:

Contracting Officer Office of Acquisitions National Institute of Allergy and Infectious Diseases National Institutes of Health Room 3214 6700B Rockledge Drive MSC 7612

BETHESDA, MD 20892-7612

- 19 -

E-Mail: NIAIDOAInvoices@niaid.nih.gov

The Contractor shall submit an electronic copy of the payment request to the approving official instead of a paper copy. The payment request shall be transmitted as an attachment via e-mail to the address listed above in one of the following formats: MSWord, MS Excel, or Adobe Portable Document Format (PDF). Only one payment request shall be submitted per e-mail and the subject line of the e-mail shall include the Contractor's name, contract number, and unique invoice number.

[Note: The original payment request must still be submitted in hard copy and mailed to the designated billing office to meet the requirements of a "proper invoice."]

2. In addition to the requirements specified in FAR 32.905 for a proper invoice, the Contractor shall include the following information on the face page of all payment requests:

a. Name of the Office of Acquisitions. The Office of Acquisitions for this contract is National Institutes of Allergy and Infectious Diseases.

b. Central Point of Distribution. For the purpose of this contract, the Central Point of Distribution is NIAIDOAInvoices@niaid.nih.gov.

c. Federal Taxpayer Identification Number (TIN). If the Contractor does not have a valid TIN, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

d. DUNS or DUNS+4 Number. The DUNS number must identify the Contractor's name and address exactly as stated in the contract and as registered in the Central Contractor Registration (CCR) database. If the Contractor does not have a valid DUNS number, it shall identify the Vendor Identification Number (VIN) on the payment request. The VIN is the number that appears after the Contractor's name on the face page of the contract. [Note: A VIN is assigned to new contracts awarded on or after June 4, 2007, and any existing contract modified to include the VIN number.] If the Contractor has neither a TIN, DUNS, or VIN, contact the Contracting Officer.

e. Invoice Matching Option. This contract requires a two-way match.

f. Unique Invoice Number. Each payment request must be identified by a unique invoice number, which can only be used one time regardless of the number of contracts or orders held by an organization.

g. PRISM/NBS Line Item Number and associated PRISM/NBS Line Item Period of Performance.

b. Inquiries regarding payment of invoices shall be directed to the designated billing office, (301) 496-6452.

c. The Contractor shall include the following certification on every invoice for reimbursable costs incurred with Fiscal Year funds subject to the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of this contract. For billing purposes, certified invoices are required for the billing period during which the applicable Fiscal Year funds were initially charged through the final billing period utilizing the applicable Fiscal Year funds:

"I hereby certify that the salaries charged in this invoice are in compliance with the SALARY RATE LIMITATION LEGISLATION PROVISIONS Article in SECTION H of the above referenced contract."

mailto:NIAIDOAInvoices@niaid.nih.gov

- 20 -

ARTICLE G.6. INDIRECT COST RATES

In accordance with Federal Acquisition Regulation (FAR) (48 CFR Chapter 1) Clause 52.216-7 (d)(2), Allowable Cost and Payment incorporated by reference in this contract in PART II, SECTION I, the cognizant Contracting Officer representative responsible for negotiating provisional and/or final indirect cost rates is identified as follows:

Director, Division of Financial Advisory Services Office of Acquisition Management and Policy National Institutes of Health

6011 EXECUTIVE BLVD, ROOM 549C, MSC-7663

BETHESDA MD 20892-7663

These rates are hereby incorporated without further action of the Contracting Officer.

ARTICLE G.7. GOVERNMENT PROPERTY

If this RFP will result in the acquisition or use of Government Property provided by the contracting agency or if the Contracting Officer authorizes in the preaward negotiation process, the acquisition of property (other than real property), this ARTICLE will include applicable provisions and incorporate the HHS Publication, entitled, "HHS Contracting Guide for Contract of Government Property," which can be found at: http://www.hhs.gov/hhsmanuals/ logisticsmanual/Appendix Q_HHS Contracting Guide.pdf .

ARTICLE G.8. POST AWARD EVALUATION OF CONTRACTOR PERFORMANCE

a. Contractor Performance Evaluations

Interim and final evaluations of Contractor performance will be prepared on this contract in accordance with FAR Subpart 42.15. The final performance evaluation will be prepared at the time of completion of work. In addition to the final evaluation, interim evaluation(s) shall be submitted annually to coincide with the anniversary date of the contract.

Interim and final evaluations will be provided to the Contractor as soon as practicable after completion of the evaluation. The Contractor will be permitted thirty days to review the document and to submit additional information or a rebutting statement. If agreement cannot be reached between the parties, the matter will be referred to an individual one level above the Contracting Officer, whose decision will be final.

Copies of the evaluations, Contractor responses, and review comments, if any, will be retained as part of the contract file, and may be used to support future award decisions.

b. Electronic Access to Contractor Performance Evaluations

Contractors may access evaluations through a secure Web site for review and comment at the following address:

http://www.cpars.gov http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix http://www.hhs.gov/hhsmanuals/logisticsmanual/Appendix…