RFP Extension

Added: Sep 28, 2009 2:39 pm Modified: Feb 04, 2010 5:41 pmTrack Changes Amendment Number 3

SUMMARY OF CHANGES


A. This amendment is issued to make the following changes to Section M as listed below. As a result of this amendment, the hour and date specified for receipt of Offers is not extended and remains February 17, 2010.

1. Section M Evaluation Factors for Award

a. Section M.3.3.1 is deleted in its entirety and replaced with the following:

M.3.3.1. Technical, Program Management, and Past Performance Factors, Subfactors, and Elements will be rated using a Color/Adjectival rating scheme. Element ratings will be rolled up into their corresponding Subfactor rating. Subfactor ratings will be rolled up into their corresponding Factor rating.

General definitions of ratings:

EXCELLENT = BLUE Proposal meets all the Governments objectives. The Offeror demonstrates superior understanding of or insight into the requirements.

GOOD = GREEN Proposal meets the Governments objectives and contains no significant weaknesses. Appropriate corrective or mitigating actions have been proposed for potential weakness(s), problems, or risks. The proposal is good.

MARGINAL = YELLOW Proposal marginally meets the Governments objectives. The proposal reflects significant weakness(s) for which the Contractor has not identified corrective actions, or has proposed marginally effective actions, or has proposed actions which cannot be fully implemented. The proposal is barely adequate and demonstrates a marginal understanding of the requirements. Overall the proposal quality is somewhat below marginal. .

POOR = RED Proposal does not meet the Governments objectives. The proposal has deficiency(s) for which corrective actions would be ineffective or not proposed. Proposal reflects an insufficient understanding of the requirements and/or fails to demonstrate Contractor capability for meeting the requirements. Overall, the proposal quality is poor.

Added: Sep 28, 2009 2:39 pm Modified: Feb 04, 2010 3:46 pmTrack Changes SUMMARY OF CHANGES


A. This amendment is issued to make the following changes to Standard Form 33, section L and section M as listed below. As a result of this amendment, the hour and date specified for receipt of Offers is not extended and remains February 17, 2010.

1. Standard Form 33
a. Block 12 is deleted in its entirety and replaced with the following:
In compliance with the above, the undersigned agrees, if this offer is accepted on or prior to July 31, 2010, 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.
2. Section L Instructions to Offerors
a. Section L.1.13 is deleted in its entirety and replaced with the following:
The Offerors proposal shall be valid through July 31, 2010.
3. Section M Evaluation Factors for Award

a. Section M.1.1 General Basis for Contract Award is deleted in its entirety and replaced with the following:

M.1.1. GENERAL BASIS FOR CONTRACT AWARD - This will be a competitive source selection and contract award is based on a determination of Best Value to the Government (See FAR 15.101), to include the tradeoff process as described in FAR 15.101-1. This determination is based on an integrated assessment of ratings for Evaluation Factors (Section M.3.2.), Proposal Risk rating (Section M.2.1 and M.3.3.2), and Performance Risk rating (Section M.2.2 and M.3.3.3) Offeror(s) shall be responsible under the FAR procedures and shall submit proposals conforming to the solicitation requirements. The Government intends to select the source whose offer is most overall advantageous to the Government; however, the Government reserves the right to reject any or all proposals and to award no contract at all, depending on the quality of the proposal(s) submitted and the availability of funds. The Government reserves the right to conduct written or oral discussions and surveys as it deems necessary or appropriate before contract award.

The proposals shall be complete, shall arrive by the date and time indicated, and shall be compliant with all instructions. The Offeror shall refer to Section L (Instructions, Conditions, and Notices to Offerors) for proposal preparation.

It is anticipated that only one award will be made as a result of this Request for Proposal (RFP)

b. Section M.2.2 Performance Risk is deleted in its entirety and replaced with the following:


M 2.2. PERFORMANCE RISK - Performance risk assesses the Offerors ability to successfully complete relevant technical and management/risk identification efforts on time and within costs, and includes the Offerors performance record (Past Performance), if applicable and other information available on contractor responsibility (as defined in FAR Part 9). Overall performance risk will be assigned after completing Cost and Technical proposal reviews. A risk rating of Low (L), Moderate (M), and High (H) will be assessed (M.3.3.3). In those instances where there is insufficient Past Performance record for evaluation, the risk rating will be provided a neutral rating and, unless the Government otherwise learns of reasons to find a high level of risk, a moderate risk rating shall be used for the integrated assessment to cost and technical factors.

Added: Sep 28, 2009 2:39 pm Modified: Jan 19, 2010 12:19 pmTrack Changes SUMMARY OF CHANGES


A. This amendment is issued to make the following changes to sections C, E, F, L, and M as listed below. As a result of this amendment, the hour and date specified for receipt of Offers is not extended and remains February 17, 2010.


1. Section C Statement of Objectives

a. Added C.4.10 to require submission of Contractor Code of Business Ethics and Conduct per FAR 52.203-13 and FAR 3.1004(a).


2. Section E Inspection and Acceptance

a. Clause 52.246-3 Inspection of Supplies Cost-Reimbursement is deleted in full from Clauses Incorporated by Reference
b. Clause 52.246-2 Inspection of Supplies Fixed Price is directly linked to CLINs 0006, 0007, 0008, 0009, and 0010
c. Clause 52.246-7 Inspection of Research and Development Fixed Price is directly linked to CLINs 0001, 0003, 0005, 0011, and 0012
d. Clause 52.246-8 Inspection of Research and Development Cost Reimbursement is directly linked to CLINs 0002 and 0004


3. Section F Deliveries of Performance

a. For CLIN 0006, the Ship to Address is amended to read Ship in place.
b. For CLIN 0011, the quantity is amended to read 1 Technical Data Package.
c. For CLIN 0012, the quantity is amended to read 1 Drug Master File.


4. Section L Cost

a. Section L.4.1.4.6 Other Costs is deleted in its entirety and replaced with the following:

L.4.1.4.6. Other Costs. List direct costs not included in the above categories (i.e., special tooling, computer services, preservation, and packaging). Provide basis of estimate (i.e., vendor quotes, catalog pricing, subcontracting estimates). Competitive historical price information of prior purchases is adequate.



5. Section M Evaluation Factors for Award

a. Section M.1.1 General Basis for Contract Award is deleted in its entirety and replaced with the following:

M.1.1. GENERAL BASIS FOR CONTRACT AWARD - This will be a competitive source selection conducted in accordance with Federal Acquisition Regulation (FAR) 15.101.1. The contract award is based on a determination of Best Value to the Government (see FAR 15.1). This determination is based on an integrated assessment of ratings for Evaluation Factors (Section M.3.2), Proposal Risk rating, and Performance Risk rating. Offeror(s) shall be responsible under the FAR procedures and shall submit proposals conforming to the solicitation requirements. The Government intends to select the source whose offer is most overall advantageous to the Government; however, the Government
reserves the right to reject any or all proposals and to award no contract at all, depending on the quality of the proposal(s) submitted and the availability of funds. The Government reserves the right to conduct written or oral
discussions and surveys as it deems necessary or appropriate before contract award.

The proposals shall be complete, shall arrive by the date and time indicated, and shall be compliant with all instructions. The Offeror shall refer to Section L (Instructions, Conditions, and Notices to Offerors) for proposal preparation.

It is anticipated that only one award will be made as a result of this Request for Proposal (RFP)


Questions and Answers



B. This amendment is issued to answer the questions submitted as of January 7, 2010 and listed below. As a result of this amendment, the hour and date specified for receipt of Offers is not extended and remains February 17, 2010.


1. What is the technology readiness level of an acceptable product?

The minimum acceptable Technology Readiness Level (TRL) for this solicitation is a TRL 3. The definition of a TRL 3 product is detailed in the attached memorandum dated December 17, 2008.


2. Is there a target product profile for this countermeasure? If so, where is it published?

" The Capability Development Document (CDD) is in draft form and is not published at this time. The target product profile is described in the Statement of Objectives (SOO), as shown in the references below.
" A therapeutic countermeasure that demonstrates efficacy when administered a minimum of 4 hours following exposure to radiation sufficient to cause the gastrointestinal (GI) subsyndrome of Acute Radiation Syndrome (ARS). (C.2.)
" Countermeasure exerts its effect directly on the incipient or manifest radiation injury suffered by the GI tract. (C.2.)
" Minimal logistical burden
o The medical radiation countermeasure shall be operational across a wide range of temperatures. It is favorable to have a shelf life greater than 2 years at a storage temperature of 20-35 degrees Celsius. (C.3.3.1)
o A final product formulation suitable for administration in humans and a delivery system suitable for military use. (C.3.3.2)


3. What does the Government require as a back up for insurance estimates?

The Government requires vendor quotes, catalog pricing, or competitive historical price information of prior purchases. See amended Section L.4.1.4.6 - Other Costs.


4. If the Offeror cannot procure insurance, will the Government provide indemnification?

Under 10 USC 2354 (DFARS 235.070-1) SEC ARMY may, if justified by an awardee, authorize indemnification of resulting contract(s) for advanced development. Indemnification before award is not feasible and only a contract may be indemnified. Proposals shall not be conditioned on receipt of indemnification and performance shall not be delayed because of a request of indemnification is being processed.


5. On Pg. 12, CLIN 0006 states within 1 year of exercise of 2,500, to ship to address same as above which means ship to CBMS-MITS 64 Thomas Johnson Drive Frederick, MD 21702. Please confirm that 2,500 MRC are to be delivered to this address.

Section F - CLIN 0006 was amended to Ship in place.


6. Likewise, on Pg. 12, CLINs 0007, 0008, 0009, 0010 state to deliver the MRC to Ship in place. Does this mean to retain the MRC in storage at the location where it was developed? Please clarify.

The delivery location will be provided following exercise of the option.


7. Given the nature of this type of research and development effort, and that the majority of the proposed CLINs are to be Firm Fixed Price, and that they will most likely go out several years, along with the current volatile economy, would the Government consider receipt of a legitimate estimate of the pricing for the out-years? We are certain that the pricing will change over time of which we have little control. Will the Government accept this type of pricing estimate for initial consideration, and then permit the Offeror to update the costs annually?

The Government understands the nature of the Research and Development effort. Firm-fixed pricing is required for low-risk areas and the Government will not accept updating the costs annually for Firm-fixed price CLINs.


8. By my reading, funding is anticipated in October 2010 and the first deliverable is due June 2011. That first deliverable includes the completion of a Phase I trial. Therefore, would an IND need to be filed within 2-3 months of funding?

The timing of IND filing is specific to each Offeror. However, it is expected that the Offeror complete the activities associated with CLIN 0001 and CLIN 0002 no later than June, 2011. Funding will be available at time of contract award and contract award is anticipated in May/June 2010.


9. When would you anticipate having completed the review and being able to commit that funding will be forthcoming?

As shown in Section L Instructions to Offerors, additional funds are envisioned in subsequent DoD Budgets, starting with the FY12-17 POM (L.1.1.9). A better estimate of the FY12-17 POM funding will be available by mid-FY11. However, the funding provided in L.1.1.9 provides the current planned budget for this program. Unfunded requirements and additional POM funding will be requested in addition to the current budget.


10. Given that $12.9M has been budgeted through 2013, will there be multiple awards under this solicitation?

As stated in Section M.1.1 The Government intends to select the source whose offer is most overall advantageous to the Government; however, the Government reserves the right to reject any or all proposals and to award no contract at all, depending on the quality of the proposal(s) submitted and the availability of funds. It is anticipated that only one award will be made as a result of this Request for Proposal.


11. Can you further define the Phase 1 study? Is the Phase 1 study the complete human safety trial (dose finding, safety, large population)?

The Phase 1 study is the complete human safety trial needed to initiate expanded Phase 2 clinical trials. Any human safety studies needed for FDA approval that are not completed shall be included in the technical approach provided in the proposal in order to complete Phase 1.


12. Is it correct that the Past Performance section requires both submission by the Offeror (us) and reports by the PO's on ongoing and prior Government grants and contracts?

Yes, the Offeror shall provide Attachment A Past Performance Information as described in L.3.3.1. The Offerors Reference(s) noted in Attachment A shall provide Attachment B Past Performance Questionnaire as described in L.3.3.2.


13. Is it acceptable for Offerors to propose a higher cost than the current funding listed at L.1.1.9?

Yes, it is acceptable to propose a higher cost than the current funding listed at L.1.1.9. As stated in the Notes section of L.1.1.9, strict adherence to the funding profile incorporated herein shall not be a consideration in the source selection decision and Offerors are encouraged to develop best-value proposals. The current funding profile is used as a guideline for Offerors; however, additional POM funding will be requested in addition to the current budget.


14. Is it feasible that funding will be made available other than what is listed at L.1.1.9?

The current funding profile is used as a guideline for Offerors; however, unfunded requirements and additional POM funding will be requested in addition to the current budget. The Government makes no assurances that the projected funds shall be made available for this program nor shall this solicitation provision be the basis for a claim under the contract in the event the projected funds fail to materialize. This provision will not be incorporated in any contracts awarded as a result of this solicitation. This answer shall be considered part of Section L.

Added: Sep 28, 2009 2:39 pm Modified: Dec 24, 2009 9:35 amTrack Changes Presolicitation notice originally posted on 28 September 2009 is modified to provide location for accessing RFP. The RFP is currently available at the following website:
http://www.jpeocbd.osd.mil/packs/Default.aspx?pg=1214&title=CBMS%20-%20Current%20Opportunities

Added: Sep 28, 2009 2:39 pm The U.S. Army Space and Missile Defense Command (USASMDC) is providing notice that a Request for Proposal (RFP), W9113M-09-R-0010, for the Advanced Development of Medical Radiation Countermeasure (MRC) will be issued on or about 13 October 2009 with an anticipated contract award on or about 31 March 2010. This requirement is a 100% small business set-aside.
Small business prime contractors are required to comply with FAR 52.219-14, Limitations on Subcontracting and 13 CFR 125.6 (known as the 50% rule). Rules on affiliation and joint ventures are at FAR 19.101, 13 CFR 121.103, 13 CFR 124.513 and 13 CFR 125.6. Under the 50% rule where the preponderance of support is for supplies (other than procurement from a nonmanufacturer of such supplies), the concern shall perform work for at least 50% of the cost of manufacturing the supplies, not including the cost of materials. The small business prime contractor must meet this requirement (1) individually, or (2) together with other small business members of a formal joint venture, or (3) together with a small number of small business subcontractors forming an informal joint venture, in which those subcontractors meet the definition of ostensible subcontractor as set forth in 13 CFR 121.103(h)(4). Team members in such formal and informal joint ventures are exempt from affiliation rules under the conditions set forth in 13 CFR 121.103(h)(3). There is no limit to the number of other team subcontractors or size status of subcontractors.
In accordance with DFARS 252.204-7004, all interested contractors shall be registered in the Central Contractor Registration (CCR) database. CCR registration can be accomplished at the following website: http://www.ccr.gov. The North American Industry Classification System (NAICS) code for this procurement is 541711, Research and Development in Biotechnology, with a size standard of 500 employees. The Government does not intend to use FAR Part 12 for this acquisition.
The MRC shall be a drug or biologic that can be expeditiously developed, and when used after exposure to doses of ionizing radiation sufficient to cause the gastrointestinal (GI) subsyndrome of acute radiation syndrome (ARS), will either prevent/reduce the extent of incipient radiation injury or promote repair of manifest radiation injury to allow preservation/restoration of the anatomic integrity and normal physiologic functioning of the GI tract resulting in increased survival, reduced incapacitation, and sustained operational effectiveness. MRCs carrying logistical burdens (e.g., special handling or storage conditions lower than -20 degrees Celsius) may be acceptable, but are much less desirable. The MRC should be delivered by minimally invasive means and in as few doses as possible.
Development and delivery of the MRC product shall require a Contractor to coordinate and manage the activities associated with advanced development of the product. The Contractor will be responsible for conducting the various activities associated with drug/biologic development in manners that are consistent with eventual approval or licensure by the Food and Drug Administration (FDA). Associated Technology Development activities will include, but are not limited to: manufacturing process development and related tasks, current Good Manufacturing Practices (cGMP)-compliant small-scale manufacturing and testing of the radiation countermeasure product, Good Laboratory Practices (GLP)-compliant acute toxicology testing in animals, pilot animal efficacy studies, filing of an Investigational New Drug (IND) application, and conducting a Phase I clinical trial in accordance with FDA regulations and guidelines. After successful completion of the Technology Development efforts and Government review, the Contractor shall conduct necessary follow-on advanced developmental activities leading to FDA approval of the developmental end item. The Contractor will be required under the base contract to provide one (1) FDA approved MRC. The Government anticipates FDA approval of the MRC within 3 to 6 years after contract award, but all proposed delivery schedules will be evaluated. A CLIN for production quantities of the FDA approved MRC will also be included in the awarded contract as an option.
Proposals will be evaluated based on Factors, Subfactors, and Elements representing the Best Value to the Government. Delivery schedules of the FDA approved MRC shall be proposed by the offerors and will be used as one of the evaluation criteria associated with a Best Value evaluation. The current FY10-15 program/budget funding for this project is $12.29M. Additional funding is envisioned in the subsequent DoD Budgets, starting with the FY12-17 Program Objectives Memorandum. All interested parties can view, download, and print a copy of the solicitation and any resulting amendments when released on or about 13 October 2009 at the JPEO-CBD website hyperlink http://www.jpeocbd.osd.mil/packs/Default2.aspx?pg=180. Scroll down to the bottom of the webpage and select the RFP number W9113M-09-R-0010. No paper copies of the RFP will be provided and no mailing list will be maintained because the acquisition will be posted on the above website. Questions or correspondence should be directed by e-mail to Sandra.Oconnell@us.army.mil or Drake.Russell@us.army.mil, please reference RFP number W9113M-09-R-0010.