2014013_Amendment2.pdf

AMENDMENT #2, RFP NIAID-DAIDS-NIHAI2014013

Amendment No. 2

RFP No. NIAID-DAIDS-NIHAI2014013 “NIAID Process and Analytical Support for Development of HIV Vaccines”

Solicitation Number:

Amendment Number:

Amendment Issue Date:

NIAID-DAIDS-NIHAI2014013

Two (2)

August 5, 2015

Proposal Intent Response Sheet:

Response Date:

Friday, August 14, 2015 at 3:00 PM, Local Time (Changed)

Thursday, September 17, 2015 at 3:00 PM, Local Time (Unchanged)

Issued By: Michelle L. Scala Contracting Officer

OA/DEA/NIAID/NIH/DHHS

5601 Fishers Lane, Room 3D10, MSC 9821 Bethesda, Maryland 20892-9821

Points of Contact: PRIMARY:

Kim.Brookens@nih.gov Kim Brookens, Contract Specialist Phone: 301-761-5140

SECONDARY:

mscala@niaid.nih.gov Michelle L. Scala, Contracting Officer Phone: 240-669-5156

The purpose of this amendment is to answer questions from potential offerors regarding the solicitation and extend the submission due date for the Proposal Intent Response Sheet.

Offerors must acknowledge receipt of this amendment by identifying this amendment number and date of the amendment on each copy of the proposal submitted. Failure to receive your acknowledgement may result in the rejection of your proposal. Except as provided herein, all terms and conditions of the solicitation remain unchanged and in full force and effect.

mailto:Kim.Brookens@nih.gov mailto:anhughes@niaid.nih.gov

Questions from Potential Offerors:

Question 1:

The RFP instructions indicate that a Vertebrate Animal Section must be included in the contractor’s technical proposal. It is our understanding that the proposed contract does not include immunogenicity, protection and/or toxicity testing. Therefore, we do not believe animal studies will be required. Please confirm.

Response to Question 1:

There may be activities that require the development of specific reagents in animals, such as antibodies. The request for the Vertebrate Animal Section was included to cover this possibility.

Question 2:

It is assumed that development of a potential RCB will utilize a cell line (e.g., DG44) that has a FDA path to clinical trials. Several licensing steps will be required to obtain a cell line for use in this work. Will the government provide the contractor with access to such a cell line with the appropriate licenses or will the contractor be required to budget for this and workout the required licensing terms for use in the proposed work?

Response to Question 2:

This would need to be decided on a case by case basis. We recommend that the offeror note these potential costs in the budget.

Question 3:

Will the projects be established as bona fide research collaborations between Contractor and Supplier, consistent with Contractor’s tax-exempt status?

Response to Question 3:

This will be a contract, subject to all of the terms and conditions associated therewith.

Under federal contracts, the Government and the Contractor have a binding relationship.

The Government’s role is to direct the work and pay the Contractor for the work and the Contractor’s role is to carry out the work.

Question 4:

Will new intellectual property developed by Contractor in a project be handled in accordance with 37 CFR 401.14?

Response to Question 4:

Yes. Please see the intellectual property information included in the RFP. Links to additional information are included on Pages 67 and 68. These links are:

http://www.gpo.gov/fdsys/pkg/FR-1999-12-23/pdf/99-33292.pdf http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

Question 5:

If improvements or modifications are made by Contractor to Supplier’s product or formulation during the course of a project, will rights in that new Intellectual Property (IP) reside with Contractor?

Response to Question 5:

Yes. Please see the intellectual property information included in the RFP. Links to additional information are included on Pages 67 and 68. These links are:

http://www.gpo.gov/fdsys/pkg/FR-1999-12-23/pdf/99-33292.pdf http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html

Question 6:

If Contractor uses its existing (background) IP in a project, will the terms of any use of that background IP by Supplier be established by arms-length negotiation (e.g., separate license arrangement).

Response to Question 6:

Per. Article B.4. ADVANCE UNDERSTANDINGS, a. Protection of Proprietary Data:

Materials generally are supplied to the Government under conditions outlined in NIAID’s standard Material Evaluation Agreement (MEA) or other appropriate documents. A separate license agreement would be negotiated as necessary.

Question 7:

On Page 64 of the RFP, under Technical Proposal Instructions, reference is made to “unusual expenses”. Please clarify how “unusual expenses” should be defined?

Response to Question 7:

Please detail any expenses that may not be typical for the method described.

Question 8:

In Attachment 3, under Task Area 1, and in Attachment 4, under Task Order 001-1, references are made to ad hoc meetings and teleconferences. What should the assumption be regarding the frequency of ad-hoc meetings and teleconferences with the NIH and tech http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html http://grants.nih.gov/grants/guide/notice-files/NOT-OD-03-032.html advisory/regulatory groups, beyond initiation and annual meetings? Shall we assume some regular interaction, for example 1-2 hours bi-weekly or monthly?

Response to Question 8:

Regular ad-hoc meetings and teleconferences are not typically necessary. However, the Contractor will need to participate in ad-hoc meetings and teleconferences if a need arises. You may include costs for these meetings in your cost proposal as you deem necessary.

Question 9:

In Attachment 4, under Task Order 001-1 of the RFP also makes reference to ad hoc reports. What should the assumption be regarding the frequency of these ad hoc reports?

Response to Question 9:

Ad hoc reports will be required if a need arises. You may include costs for these reports in your cost proposal as you deem necessary.

Question 10:

The RFP indicates that activities under Task Area 1 will be contracted annually, a base period of one year and options 1- 6 for 12 month increments for future years. Please see the questions below:

a. Task Order 1-1 - Page 95 of PDF states that a transition plan is required 3 months prior to the expiration date of the Task Order. Is a transition plan required 3 month prior to the end of each annually renewed Task Order? Or if this is renewed is it not required until the next renewal period end date?

Response to 10.a:

If an Option is not exercised, a transition plan will be due three months before the expiration of that Task Order. If an Option(s) has been exercised, the transition plan will be due at the end of the exercised options.

b. Our assumption is that work under Task Areas 2 and 3 will be for periods longer than 12 months. Should Task Orders in Task Areas 2 and 3 be awarded for periods longer than 12 does NIH expect to extend the period of Task Order 1 to cover the entire period of activities under the remaining Task Areas?

Response to 10.b:

Task Order 1 is for a Base Period with one year Options. If all Options are exercised, the total period of performance of the contract will be for 7 years. An extension beyond that period is not planned at this time.

Question 11:

Under Attachment 5, Task Order 002-1, reference is made to Mass Spectrometry Methods to Determine the Glycosylation of HIV Env Vaccine Candidates. We interpret the requirements to include ALL methods required to characterize and release/QC materials. Our intent is to include all those methods in this sample Task Order 002-1. Is that acceptable?”

Response to Question 11:

We do not want or expect the response to contain all methods required for characterization and release.

Question 12:

What is the turnaround time for NIAID to respond to questions under this RFP? Also, does NIAID plan to issue a complete list of Questions and Answers for this RFP?

Response to Question 12:

We answer questions as they arise. The responses to the questions are published in FedBizOps as an amendment to the RFP so that all may benefit from the questions and answers.

PROPOSAL INTENT RESPONSE SHEET Page 1 of 1 ATTACHMENT 2

PROPOSAL INTENT RESPONSE SHEET

NIAID PROCESS AND ANALYTICAL SUPPORT FOR DEVELOPMENT OF HIV VACCINES

RFP-NIAID-DAIDS-NIHAI2014013

Please review the attached Request for Proposal. Furnish the information requested below and return this page by August 14, 2015. Your expression of intent is not binding but will greatly assist us in planning for proposal evaluation.

[ ] DO INTEND TO SUBMIT A PROPOSAL

[ ] DO NOT INTEND TO SUBMIT A PROPOSAL FOR THE FOLLOWING

REASONS:

Company/Institution Name (print): ______________________________________

Address (print): _______________________________________________________

Project Director's Name (print): ________________________________________

Title (print): _________________________________________________________

Signature/Date: ________________________________________________

Telephone Number and E-mail Address (print clearly):

*Name of individual to whom electronic proposal instructions should be sent:

Name: ___________________________________________________

Title: ___________________________________________________

E-Mail Address: __________________________________________

Telephone Number: _______________________________________

Names of Collaborating Institutions and Investigators (include Subcontractors and Consultants)

(print):

(Continue list on a separate page if necessary)

RETURN VIA FAX OR E-MAIL TO:

OA, DEA, NIAID, NIH

5601 Fishers Lane, Room 3D10, MSC 9821

Bethesda, MD 20892-9821

Attn: Kim Brookens RFP No. NIAID- DAIDS-

NIHAI2014013 FAX# (301) 480-4675

Email: kim.brookens@nih.gov mailto:rosemary.gomes@nih.gov