N02CN75014-45_Amendment_2_-_CLARIFICATIONS.pdf

OMB No 0990-0115

1. CONTRACT ID CODE PAGE OF PAGES

AMENDMENT OF SOLICITATION/MODIFICATION OF CONTRACT N/A 1 47

2. AMENDMENT/MODIFICATION NO. 3. EFFECTIVE DATE 4. REQUISITION/PURCHASE REQ. NO. 5. PROJECT NO. (If applicable)

1 March 26, 2018 N/A

6. ISSUED BY CODE 7. ADMINISTERED BY (If other than Item 6) CODE N/A National Institutes of Health National Cancer Institute Office of Acquisitions 9609 Medical Center Dr., Rm 1E646, MSC 9705 Bethesda, MD 20892-9705

8. NAME AND ADDRESS OF CONTRACTOR (No. Street, County, State and ZIP: Code) ( ) 9A. AMENDMENT OF SOLICITATION NO.

TO ALL POTENTIAL OFFERORS

N02CN75014-45

9B. DATED (SEE ITEM 11)

Feb. 23, 2018

10A. MODIFICATION OF CONTRACT/ORDER NO.

10B. DATED (SEE ITEM 13)

CODE FACILITY CODE

11. THIS ITEM ONLY APPLIES TO AMENDMENTS OF SOLICITATIONS

The above numbered solicitation is amended as set forth in Item 14. The hour and date specified for receipt of Offers is extended, is not extended.

Offers must acknowledge receipt of this amendment prior to the hour and date specified in the solicitation or as amended, by one of the following methods:

(a) By completing Items 8 and 15, and returning one (1) copy of the amendment; (b) By acknowledging receipt of this amendment on each copy of the offer submitted;

or (c) By separate letter or telegram which includes a reference to the solicitation and amendment numbers. FAILURE OF YOUR ACKNOWLEDGMENT TO BE RECEIVED AT THE PLACE DESIGNATED FOR THE RECEIPT OF OFFERS PRIOR TO THE HOUR AND DATA SPECIFIED MAY RESULT IN REJECTION OF YOUR OFFER. If by virtue of this amendment you desire to change an offer already submitted, such change may be made by telegram or letter, provided each telegram or letter makes reference to the solicitation and this amendment, and is received prior to the opening hour and data specified.

12. ACCOUNTING AND APPROPRIATION DATA (If required)

13. THIS ITEM APPLIES ONLY TO MODIFICATIONS OF CONTRACTS/ORDERS,

IT MODIFIES THE CONTRACT/ORDER NO. AS DESCRIBED IN ITEM 14.

( ) A. THIS CHANGE ORDER IS ISSUED PURSUANT TO: (Specify authority) THE CHANGES SET FORTH IN ITEM 14 ARE MADE IN THE CONTRACT ORDER NO. IN ITEM 10A.

B. THE ABOVE NUMBERED CONTRACT/ORDER IS MODIFIED TO REFLECT THE ADMINISTRATIVE CHANGES (such as changes in paying office, appropriation date, etc.) SET

FORTH IN ITEM 14, PURSUANT TO THE AUTHORITY OF FAR 43.103(b).

C. THIS SUPPLEMENTAL AGREEMENT IS ENTERED INTO PURSUANT TO AUTHORITY OF:

D. OTHER (Specify type of modification and authority)

E. IMPORTANT: Contractor is not, is required to sign this document and return 1 copy to the issuing office.

14. DESCRIPTION OF AMENDMENT/MODIFICATION (Organized by UCF section headings, including solicitation/contract subject matter where feasible.)

PURPOSE: 1) To provide clarification to questions received by the deadline for questions, March 9, 2018, on RFP N02CN75014- 45, “Centralized Chemopreventive Agent Repository and Chemistry Support”, and subsequently revised RFP Attachment 17, Additional Business Proposal Instructions.

Deadline for Questions: March 9, 2018; 3:00pm ET (Unchanged)

Proposal Due Date: April 9, 2018; 12:00pm ET (Unchanged)

Except as provided herein, all terms and conditions of the document referenced in Item 9A or 10A, as heretofore changed, remains unchanged and in full force and effect.

15A. NAME AND TITLE OF SIGNER (Type or print) 16A. NAME AND TITLE OF CONTRACTING OFFICER (Type or print)

Catherine A. Muir Contracting Officer, PCPSB, OA, NCI, NIH, DHHS

15B. CONTRACTOR/OFFEROR 15C. DATE SIGNED 16B. UNITED STATES OF AMERICA 16C. DATE SIGNED

(Signature of person authorized to sign)

BY __________________________________ ________

(Signature of Contracting Officer)

March 26, 2018

NSN 7540-01-152-8070 30-105 STANDARD FORM 30 (REV. 10-83)

PREVIOUS EDITION UNUSABLE Computer Generated Prescribed by GSA

FAR (48 CFR) 53.243

Solicitation N02CN75014-45 Amendment #2 –Questions/Responses

“Centralized Chemopreventive Agent Repository and Chemistry Support”

Solicitation N02CN75014-45 “Centralized Chemopreventive Agent Repository and Chemistry Support”

1. What will be the site of performance for this contract?

Response to #1: The place of performance will be the Offeror’s worksite. The Offeror will supply the physical plant as recommended in the RFP at a site within the United States. The Government will not be choosing the site.

2. Is the final product tablet-based or liquid-based (filled in vials)?

Response to #2: Final drug products may be any of the common pharmaceutical dosage forms. This includes tablets, capsules, topicals, oral liquids, injectables, etc.

3. Does the requirement for the clean agent fire suppression system apply to all activities in the solicitation?

Would laboratory/storage/fill & finish activities be exempt?

Response to #3: The fire suppression system is required for the inventory warehouse. The laboratory facility doesn’t need the fire suppression system if it is located apart from the inventory.

4. Is there any information on the instrumentation needed for the lab/formulation studies? Will some of this be provided by the Government?

Response to #4: The Government will not be supplying any lab/formulation equipment. Please see RFP SECTION C, ARTICLE C.1.a for information.

5. Task Area 3 - Is the Government going to need chemical structure search capabilities (e.g. Chem Axon) or is simple structure representation and inventory control capability enough?

Response to #5: The Government will not need any chemical search capabilities.

6. Task Area 3 - Does the Government have servers for this effort and are these Government Furnished Equipment (GFE)? If so, how many, age, make/model?

Response to #6: The Government does not have servers, and will not be supplying servers for this effort.

Please see RFP SECTION C, ARTICLE C.1.a for information.

7. Task Area 4 - Item 4. D. of the SOW states the following: "D. Utilize the existing system Inventory Management System to track the location and amount of all materials on-site, in-route, and off-site and provide an Inventory management system Report with current status itemized as requested by the COR."

What is the existing Inventory Management System currently in use? The current inventory management system is not referenced in the list of Government Property. Is the current system one that the Government is transferring with the new contract?

Response to #7: The current inventory system being used is the CambridgeSoft Inventory system. This is a SQL database system that is an off-the-shelf program. The Government will not be supplying an inventory system. Prospective Offerors would be expected to utilize an inventory management system that is compatible with CambridgeSoft to facilitate the transfer of existing inventory information in a seamless manner.

8. To enable all bidders to understand the amount of agents being stored and so the Government can make a like comparison among all bidders to facilitate RFP Price Evaluations and comparisons, can the Government provide a copy of the last Monthly and Annual Technical Progress Reports (Spreadsheet Summary of agent name, protocol number, investigator, study title, supplier, study allocation and remaining inventory of agent)? As this is a Government Owned Report we believe this will support the pricing for all bidders.

Response to #8: In lieu of providing these reports, which contain confidential information, a copy of the current “DCP Repository Inventory” report as of 3/14/2018 ((27) pages total) is being provided at the end of this Amendment #2. The report provides the type of materials, quantities, unit of measure, and storage condition.

9. To enable all bidders to properly evaluate and price out the work, can the Government provide the completed itemizations of the entire repository inventory as provided to the COR in the Inventory Tracking System employed in the current Contract?

Response to #9: A copy of the itemized list of the current inventory entitled “DCP Repository Inventory” report as of 3/14/2018 ((27) pages total) is provided at the end of this Amendment #2.

10. To enable all bidders to properly price the on-going Operational and Maintenance and/or Licensing/Software Support Contract associated with the Inventory Tracking System, please provide the name of the product and vendor for the Inventory Tracking System currently being used on the Contract and confirm that this is Government Owned, Government Furnished Equipment/Government Furnished Information (i.e. GFP/GFI).

Response to #10: The current inventory system being used is the CambridgeSoft Inventory system. This application will not be supplied as Government Furnished Equipment. The existing inventory information will be provided to facilitate a seamless transfer.

11. Please confirm the Inventory Tracking System (i.e. tracking software, tracking program) will be provided to the Awardee as GFE/GFI at contract award or during the Transition Phase of the contract.

Response to #11: The Awardee will be provided the information contained in the existing inventory tracking system for transfer to any comparable inventory tracking system. The specific software will not be provided by the Government.

12. Please confirm to all bidders that all source code and object code developed, modified, and/or enhanced under this contract associated with any software programs developed under the contract with Government funding will be delivered to the Awardee at contract award or during the Transition Phase of the contract.

Response to #12: The current inventory software has not been modified or enhanced in any way. Please refer to the response to question #7 above for additional information.

13. Task Areas 1- Initial Transition. May all bidders assume that 100% of the vials or containers are currently labeled with barcode-readable labels identifying the contents upon receipt of agents? If not, what percentage of materials will required to be re-inventoried and relabeled during the Initial Transition or will the incumbent be required to perform this task before transition?

Response to #13: Approximately 99.5% of the existing inventory is labeled with barcodes. An Awardee would be expected to conduct a complete inventory of all materials during the transition period.

14. Attachment # 5 - Government Furnished Property appears to be incomplete. Based on the requirements for: +2 to +8° C Refrigerator, -15 to -20°C Freezer, -70 to -90°C Ultra low temperature freezer, and LN2 tanks, will the GFP be modified to include the Government Owned Freezers, as well as any other specialized equipment (analytic equipment, laboratory equipment, web servers, personal computers, LN2 dewars, flow and desiccator cabinets, safety cabinets, Composite safe for quarantined storage, stainless steel wire shelving, etc.) purchased at Government expense under the current Cost Reimbursement HHSN261201100046C contract?

Response to #14: The current contract HHSN261201100046C does not have Government Furnished freezers. Please refer to the revised RFP Attachment #17 in this Amendment #2 a uniform cost assumption concerning freezers. There is no specialized equipment purchased at Government expense on the current contract HHSN261201100046C to be transferred.

15. Based on Attachment # 5 - Government Furnished Property that lists 5 Sensors that generally are utilized in ultra-low freezers, will the GFP list be modified to include such Government Owned equipment?

Response to #15: Please refer to the response to question #14 above for additional information. The sensors listed in Attachment #5 were inadvertently added, and therefore, will not be provided by the Government.

16. If no Freezers or specialized equipment are to be transferred to the Awardee as GFP, how will the Government address the increased costs all bidders will have, except the incumbent, to derive a fair and reasonable cost/price evaluation? Will these costs be decremented or removed from the price evaluation so a fair comparison in prices between all the proposals can be evaluated?

Response to #16: The current contract HHSN261201100046C does not have Government Furnished freezers. Please refer to the revised RFP Attachment #17 in this Amendment #2 a uniform cost assumption concerning freezers.

17. While the Uniform Cost Assumptions note that the Environmentally controlled space for refrigerated storage (“-10E, -30EC, -4EC and 2-8EC”) temperature or humidity-sensitive materials is about 3,000 cubic feet total area and the SOW references additional storage requirements at -15°C to -20°C, to assure all bidders pricing is easily comparable for Cost/Price evaluation purposes, please provide the following information:

Equip./Item Capacity (cu. Ft.) Dimensions of Unit (Height, Width, and

Length)

Quantity Age

+2°C to +8°C Refrigerator

1,400

‐15 to ‐20°C Freezer 900

‐30°C Freezer N/A

‐70°C to ‐90°C ULT Freezer

Ambient Storage Space

Listed in the RFP

LN2 tanks NMT 10

Response to #17: None of the equipment in use is GFE, therefore the overall dimension, quantity and age are not relevant. Any refrigeration equipment that provides the listed storage capacity will be considered.

18. To ensure all bidders properly assess the costs for Analytical Services, can the Government provide the type of analytical services that are required under the program, as well as the current list of analytical equipment being employed to provide such analytical services? Can the Government provide the name, model number, manufacturer, and quantity of such equipment to ensure all bidders include such analytical services in their bid? Bidders require this information to properly estimate the calibration, repair and equipment costs.

Response to #18: The analytical equipment used on the current contract HHSN261201100046C belongs to the Incumbent. No analytical equipment on the current contract HHSN261201100046C is GFE. The Government does not recommend any specific manufacturer for this equipment. The analytical equipment utilized may include 13C-NMR, 1H-NMR, FT-IR, LC, HPLC, GC, MS, LC-MS, Dissolution apparatus, Karl-Fischer apparatus and others as needed. The Awardee need not have all instrumentation in-house and may outsource some testing as needed.

19. Attachment 3 - Task 11: Can the Government provide details about the virus seed banks currently being used? What expression vector systems are currently being used?

Response to #19: The virus seed banks are proprietary and confidential. The only expression system currently used is the baculovirus vector system.

20. Attachment 3 - Task 11: Can the Government provide details about the other host cells being used for expression besides Sf-9?

Response to #20: The only cell line used now is sf-9 cells but that does not preclude others in the future at the task order level.

21. Are on board temperature data recorders required for any shipments? If yes, please specify which shipments require temperature data recorders.

Response to #21: Shipments of temperature sensitive materials are sent with temperature data recorders.

22. If the response to questions # 22 (NOW 21 DUE TO ORDERING IN THIS AMENDMENT) is affirmative, does the receiving site need the ability to download the recorder data upon receipt of the shipment?

Response to #22: The NCI has not required this for shipments to date, and is not projected to be needed for this requirement.

23. In order for all bidder's to be evaluated on an equal basis, what is the percentage of shipments for each type of shipment task that will utilize the approximate payload sizes of 3,10, 15, and 20 cubic inches?

Response to #23: Please see the quantities in the table below.

Att.

#17 Ref.

Shipment Type Total Number of Shipments according to

UCA

Number of shipments with payload size up to 3in3

Percentage of shipments with payload size up to 10in3

Percentage of shipments with payload size up to 15in3

Percentage of shipments with payload size up to 20in3

3 Pre‐clinical in‐vivo and in‐ vitro studies use up to thirty (30) agents per year.

Shipments

5 10 10 5

4 Agent Purchases (and shipping) Ten (10) to twenty‐five (25) new in vitro screening and regulatory toxicology studies

Shipments

5 10 10 5

5 Agent Distribution/Shipping:

Anticipated clinical trials will require uninterrupted supply of about twenty

(20) agents to approximately 100,000 subjects located at approximately fifty

(50) different centers

Shipments

10 15 15 10

24. In order for all bidder's to be evaluated on an equal basis, what is the percentage of shipments for each type of shipment task that will require cold chain management @ 2-8 °C, @-20°C, @-80 °C, @VP LN2?

Response to #24: Please see the quantities in the table below.

Att.

#17 Ref.

Shipment Type Total Number of Shipments according to

UCA

Number of Shipments with transit temperature of ambient/CRT

Number of shipments with transit temperature range of 2‐8 °C

Number of shipments with transit temperature range of ‐20 °C

Number of shipments with transit temperature range of ‐80 °C

Number of shipments with transit temperature range of (VP

LN2) ‐ 165 °C

3 Pre‐clinical in‐ vivo and in‐ vitro studies use up to thirty

(30) agents per year.

Shipments

15 5 0 10 0

4 Agent Purchases (and shipping) Ten

(10) to twenty‐ five (25) new in vitro screening and regulatory toxicology studies

Shipments

15 5 0 10 0

5 Agent Distribution/Shi pping:

Anticipated clinical trials will require uninterrupted supply of about twenty (20) agents to

Shipments

30 15 0 5 0 approximately 100,000 subjects located at approximately fifty

(50) different centers

25. Section M, Evaluations Factors, Transition – States that the Transition Plan shall demonstrate a complete understanding of repository materials and functions, including the capability of accepting existing subcontracts for reagents that are in process. In order for all bidders to have an understanding of the repository materials and subcontracts and therefore be on an equal basis with the incumbent in the understanding of the repository materials and subcontracts, will the Government provide a copy of the most recent annual report and monthly reports of the incumbent contractor with company confidential material redacted? These documents as deliverables under the contract would be Government-owned materials.

Response to #25: A copy of the itemized list of the current inventory entitled “DCP Repository Inventory” report as of 3/14/2018 ((27) pages total) is provided at the end of this Amendment #2. This list includes chemical names, amounts and storage requirements.

26. Attachment 3 - Statement of Work and Attachment 4-Sample Task Order #1- SOW are almost identical.

Are the bidders to submit two separate Proposals? One for just the Sample Task Order #1 with only the Base Year priced? And the other proposal for the main Attachment 3-SOW that is to price the Base Year and the Option Periods that will provide the budget for the full period of performance?

Response to #26: The cost reimbursement, Sample Task Order #1 is for a Period of Performance of twelve (12) months, with no term options. Its SOW is to include the majority of the IDIQ SOW task areas for pricing purposes. It is anticipated that the Sample Task Order #1 would be the first awarded task order. The Period of Performance for the IDIQ contract will be sixty (60) months base with no term options. Please see revised Attachment #17 for clarification on the business proposal format.

27. Technical Proposal Instructions – Offerors are instructed to submit a detailed work plan indicating how each aspect of the Base and Sample Task Order #1 Statements of Work are to be accomplished. These two Statements of Work are practically identical. Can the Government clarify what the expectation is for addressing the Sample Task Order #1 SOW as compared with addressing the Base SOW since both SOWs are nearly identical?

Response to #27: Please see the response to #26 for information.

28. Since Attachment 3 - SOW covers the entire program and period of performance (i.e. Base Year plus Option Periods 1-4) and Attachment 4- Sample Task Order #1-SOW appears to be ~99% identical to the Attachment 3 SOW, does the Government anticipate that the Base Year budget will be much different from one proposal to the other assuming two budgeted proposals are required to be submitted under the

RFP?

Response to #28: See responses to questions #26 and #27 for information. See RFP SECTION F, ARTICLE F.1 for the IDIQ contract Period of Performance. There will be no term options for the IDIQ contract. The task orders may be structured as base and term options as necessary.

29. All bidders understand that a Contract cannot be awarded until its Small Business Subcontracting Plan is submitted and negotiated IAW Page 74 of the RFP. Is it acceptable for bidders to submit its Small Business Subcontracting Plan at the time of the Final Proposal Revision (FPR) rather than with its proposal?

Response to #29: Because of the RFP SECTION L.1.a.c.7, and the RFP SECTION L.2.a.7, please submit the Small Business Subcontracting Plan with the proposal by the proposal due date and time.

30. For bidding purposes should all bidders assume that all equipment and facilities to be bid in support of the program will be “Contractor (bidder) Owned, or Government Owned Equipment?

Response to #30: Please refer to clarifications provided in this Amendment #2 for information.

31. On Page 49, Section C, Type of Contract and Number of Awards, it states that "It is anticipated that [one/multiple award(s)] will be made…”. Can the Government clarify if this RFP will result in one award or multiple awards as this does not appear clear from the statement in this section?

Response to #31: The text for referenced paragraph c.1 is clarified as follows: “It is anticipated that one award will be made from this solicitation and that the award will be made on/about 06/29/2018.”

32. Section M, Evaluations Factors, Transition - Since the Transition Plan weight on the RFP is represented as 10% of the scoring and the "Transition In Plan" is specifically called out in this section and in order to ensure equal evaluation of all bidders, how will the Transition In Plan be evaluated for the Incumbent Contractor if they would not technically have to provide a Transition In Plan?

Response to #32: The RFP SECTION M.3.5 has been removed. The RFP SECTION M.3.1, text and weight, have been revised as follows:

1. Technical Approach--Weight 40% The Offeror shall describe in detail the methodology and procedures planned for successfully accomplishing each section of the Statement of Work (SOW) with emphasis on the following:

a. Demonstration of an understanding of the needs of the project and an understanding of Repository operations

b. Clarity and soundness of technical approach

c. Proposed coordination and interaction with the NCI staff

d. Proposed approach to preclinical and clinical study support

e. Proposed approach for delivery of materials and services

f. Proposed approach for inventory management and quality assurance/quality control procedures

g. Proposed approach to the selection and coordination of potential subcontractors

h. Documentation of Standard Operating Procedures similar to the task areas in the SOW

i. Plans for optimizing timely performance

j. Adequacy of a transition plan(s) for assuming responsibility of support activities currently being provided to the NCI DCP via the current contract. Specifically, the plan(s) is (are) to account for the transfer, receipt and taking over the inventory of the specimens and samples from their present location. The plan should include an indication of the time needed for phase-in.

k. Adequacy of a transition plan(s) for the efficient and successful transfer of responsibilities to a potential successor at the end of the proposed contract. Specifically, the plan(s) is (are) to account for the transfer of the inventory of the specimens and samples to their next location.

Adequacy of the plan(s) for the shipment and receipt of the specimens and samples to and from one facility to another. The plan should include an indication of the time needed for phase-out.

33. Based on when the Government provides answers to the bidder’s questions, and to ensure that all bidders have reasonable time to evaluate the Government responses to the questions, will the proposal submission date of March 26, 2018 be extended to at least three weeks from the day that the answers are posted?

Response to #33: Please refer to Amendment #1.

34. The SOW appears to be almost identical for Attachment 3 and Attachment 4. In order for all Offerors to be providing consistent proposals for evaluation, please clarify if the Government is looking for two separate and distinct Technical Proposals, one (1) for the overall IDIQ and one (1) for the Sample Task Order. It is unclear what the Government would be evaluating based on the SOW being nearly identical in both attachments.

Response to #34: Please refer to Attachment #11, seventh paragraph from the top of the first page of the Attachment for clarification.

35. If the Government is looking for two (2) separate and distinct technical proposals, is the Government looking for two (2) separate and distinct Business Proposals with corresponding Budgets?

Response to #35: Please see the responses in this Amendment #2 for information.

36. Section M – Technical Approach is weighted at 30%. If the answer to the question regarding the Technical Proposals is that the Government is expecting two (2) separate and distinct Technical Proposals, is the Government’s intending to score both proposals separately and add the two scores together that would equal 30%, or will just the Sample Task Order SOW be evaluated?

Response to #36: Per the response to question #32 above, the weight of Technical Approach has been revised to 40% (see below as well). Please see the revised Attachment #17 for clarifications. The SECTION M.3 “Technical Evaluation Criteria” text has been clarified as follows:

3. TECHNICAL EVALUATION FACTORS

The evaluation factors are used by the technical evaluation committee when reviewing the technical proposals. The factors below are listed in the order of relative importance with weights assigned for evaluation purposes. Subfactors are listed in order of relative importance.

1. Technical Approach--Weight 40% The technical evaluation committee will evaluate the extent to which the proposal demonstrated successful technical approach to accomplishing the Base Statement of Work (SOW), and Sample Task Order #1 SOW. The technical evaluation committee will consider pertinent aspects to the technical approach including the following:

The Offeror shall describe in detail the methodology and procedures planned for successfully accomplishing each section of these SOWs with emphasis on the following:

a. Demonstration of an understanding of the needs of the project and an understanding of Repository operations

b. Clarity and soundness of technical approach

c. Proposed coordination and interaction with the NCI staff

d. Proposed approach to preclinical and clinical study support

e. Proposed approach for delivery of materials and services

f. Proposed approach for inventory management and quality assurance/quality control procedures

g. Proposed approach to the selection and coordination of potential subcontractors

h. Documentation of Standard Operating Procedures similar to the task areas in the SOW

i. Plans for optimizing timely performance

j. Adequacy of a transition plan(s) for assuming responsibility of support activities currently being provided to the NCI DCP via the current contract. Specifically, the plan(s) is (are) to account for the transfer, receipt and taking over the inventory of the specimens and samples from their present location. The plan should include an indication of the time needed for phase-in.

k. Adequacy of a transition plan(s) for the efficient and successful transfer of responsibilities to a potential successor at the end of the proposed contract. Specifically, the plan(s) is (are) to account for the transfer of the inventory of the specimens and samples to their next location.

Adequacy of the plan(s) for the shipment and receipt of the specimens and samples to and from one facility to another. The plan should include an indication of the time needed for phase-out.

2. Personnel--Weight 25%

The technical evaluation committee will evaluate the extent to which the proposal shows documented capability (capability is based upon appropriateness and adequacy of education and demonstrated experience) of key and other personnel to provide the full complement of technical personnel required to carry out the SOWs. The technical evaluation committee may consider personnel including the following:

The Offeror shall document staff experience to conduct this work. Documentation shall include education, training and expertise of the offeror's proposed staff. This should include:

a. Availability of personnel proposed, with letters of intent if not current employees

b. Documentation of the suitability of the Principal Investigator and other scientific personnel by recent work history and pertinent technical, scientific, managerial and business credentials.

c. Proposed amount of time each person will be devoting to this project on a yearly basis and what are each person's proposed responsibilities.

3. Facilities--Weight 20%

The technical evaluation committee will evaluate the extent to which the proposal demonstrates the availability and adequacy of the facilities, with proper equipment, to carry out the specific tasks and requirements of the SOWs. The technical evaluation committee to consider facilities that include:

The Offeror shall document the availability of adequate facilities, with proper equipment, to include:

a. Compliance with all fire and safety requirements required by the state, county, and municipality in which the site is located

b. Inert gas fire suppression system

c. Alarmed and secure storage areas

d. Separate office, pre-clinical, clinical, laboratory, quarantine, storage and shipping/receiving areas

e. Adequate analytical instrumentation installed and operational

4. Organizational Experience--Weight 15%

The technical evaluation committee will evaluate the extent to which the proposal demonstrates organizational experience, of the proposed team as a whole, to carry out the specific tasks and requirements of the SOWs. The technical evaluation committee will consider organizational experience that includes:

The Offeror shall document the organizational experience of the proposed team as a whole. This should include:

a. Documentation of proposed staff's prior experience as a unit

b. Proposed organizational hierarchy and management oversight

c. Demonstration of team performance on integrated tasks

d. Demonstration of the breadth, depth, and composite experience of the proposed team to accomplish the tasks required by the Statement of Work.

e. Suitability of back-up personnel for team members

f. Evidence of a stable workforce

5. Transition Plan-Weight 10% The Transition In Plan shall demonstrate approaches for an orderly, secure, and efficient transition and transfer of contract-related materials and activities from the Incumbent Contractor, including the secure transfer of stored organisms, specimens, chemicals, investigational agents, reagents, all related repository data, and all Government-furnished property such as freezers, refrigerators, liquid-nitrogen Dewars, automated processing equipment, and storage safes.

The Transition Out Plan shall demonstrate the efficient and successful transfer of responsibilities to a potential successor at the end of the proposed contract. Specifically, the plan(s) is (are) to account for the transfer of the inventory and data to their next location. The plan should include an indication of the time needed for transition out.

The Plan shall demonstrate a complete understanding of repository materials and functions, including the capability of accepting existing subcontracts for reagents that are in process.

37. Based on Attachment # 17-Additional Business Proposal Instructions please confirm the Government is only asking for one budgeted proposal (i.e. Only Price Sample Task Order #1 and only price for a 12 month Base Period)?

Response to #37: Please see the response to question #28 for clarification.

38. If the answer to Question 33 (NOW 37 DUE TO ORDERING IN THIS AMENDMENT) is yes, will the Government’s Section M- Cost/Price evaluation of all the bidders be based upon multiplying the Sample

Task Order #1 by five period of performances to determine the total anticipated budget of the entire program (i.e. Base Period plus 4 Option Periods).?

Response to #38: Please see clarifications in this Amendment #2 for information.

End of Amendment #2 –Questions/Responses for Solicitation N02CN75014-45

AMENDMENT #2--Attachment #17 – Additional Business Instructions

RFP N02-CN-75014-45

Attachment #17. ADDITIONAL BUSINESS PROPOSAL INSTRUCTIONS

AMENDMENT #2 NOTE: REVISIONS TO THIS ATTACHMENT ARE YELLOW-HIGHLIGHTED.

BUSINESS PROPOSAL – TABLE OF CONTENTS

SECTION 1--PROPOSAL INSTRUCTIONS & COVER SHEET (use form NIH 2043 identified in Section J)

Refer to SECTION L.2.c Business Proposal Instructions of the Solicitation. The following Additional Business Proposal Instructions reflect the requirements of this Request for Proposal (RFP) and are meant to provide additional instructions as well as uniform format for business proposals. The information provided and requested in these instructions should be used as a guide for formatting and preparing the business proposal. This information is provided in addition to instructions provided in Section L of the Solicitation.

Section L. of the Solicitation discusses the acceptable minimum requirements for the format and contents. The instructions below should be used, along with Section L. of the Solicitation to format and prepare the business proposal.

Offerors are strongly encouraged to organize and submit the business proposal in the following order and as noted below, separating the sections with a page that indicates the section number.

Organization of Business Proposal

SECTIONS DESCRIPTION INSTRUCTIONS

SECTION 1

Business Proposal Title Page

See below for specific information required on the title page

Table of Contents

(TOC)

Include page number in TOC for each Section and Discussion, Information Attachment and Appendices

Proposal Summary and Data Record (NIH-2043)

Use Attachment 12 link in Section J to access the form. Do not include SSN number on the form

Offeror’s Points of Contact

Use Attachment 15 link in Section J to access the form.

SECTION 2

Business Proposal

INFORMATION AND

DISCUSSION

Past Performance Information

Refer to Section L and M of the Solicitation

Property Discussion Section L.2.c. for instructions related to property information required

Financial Capacity Statement

Refer to L.2.c.9.d. Financial Capacity and include statement in business proposal; see below

Adequate Accounting System Certification

See below

Qualifications of the Offeror

Refer to L.2.c.10

Index of Certified Cost or Pricing Data and Information

Refer to Section L.2.c. Certified Cost or Pricing Data for instructions

ATTACHMENTS

Section K – Representatives, Certifications, and Other Statements of Offerors

Use the Attachment 6 located in Section J

Non-Disclosure Agreement

Use the Attachment 7 located in Section J and see below.

Small Business Subcontracting Plan

Use the Attachment 13 located in Section J. and see additional instructions below

Certificate of Current Cost or Pricing Data

Refer to L.2.c.4. and see below

Negotiated Indirect Rate Agreement

Provide copy of most recently negotiated Indirect Rate Agreement

Fringe Rate Policy Submit if specific approved fringe rates are not included in the negotiated Rate Agreement

Cost of Living Adjustment Policy

See below

Merit Increase Policy See below

Annual Financial Report Refer to L.2.c.12

Travel Policy Refer to L.2.c.13 and submit a copy of the current policy

Disclosure of Lobbying Activities

Use the Attachment 16 located in Section J.

SECTION 3

Sample Task Order

Discussion and Documentation

Budget - Breakdown of Proposed Estimated Costs

Submit in both PDF and Excel using Attachment 14 in Section J. See below for additional information

Budget Narrative Required for each cost element. See below for specific instructions and Refer to Section L.2.c.

Certified Cost or Pricing Data, Cost Elements

Budget Supporting Documentation

Required for each cost element. See below for specific instructions

Supporting Salary Documentation

Required for personnel proposed. See below for specific instructions

Quotations Required for unit costs more than $500 per unit and required for Government-Furnished Property (equipment at any cost). See below for specific instructions

Price Catalogues Required for unit costs more than $500 per unit.

See below for specific instructions

Signed Consultant Letter’s and/or Agreements

Required for proposed consultants

Subcontractor Documentation

Signed Commitment Letters must be submitted as part of the Technical Proposal. Additional required documentation and information must be submitted as part of the Business Proposal; See below

Draft Subcontract Agreements

Required for each proposed subcontractor (unsigned templates)

GENERAL INSTRUCTIONS

1. Submit one business proposal divided into the sections in the chart above.

2. All proposal information and documentation required as specified in the Solicitation should be included and listed in the Table of Contents with a page reference.

3. There are no page limitations to the business proposal or any sections of the business proposal.

4. ALL OFFERORS ARE REQUIRED TO SUBMIT A COST PROPOSAL FOR SAMPLE TASK ORDER 1.

DO NOT SUBMIT A COST PROPOSAL FOR THE BASE STATEMENT OF WORK.

5. The Business proposal shall be submitted electronically using the Electronic Contract Proposal System

(eCPS). Refer to Attachment 1 Packaging and Delivery of the Proposal for Use with eCPS for instructions.

No hardcopies are to be submitted.

6. Section L of the Request for Proposal (RFP) specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in the business proposal in a clearly marked section. Refer to detailed instructions below for Sample Task Order 1.

SPECIFIC INSTRUCTIONS:

The Offeror is responsible for ensuring that all required information and documentation is included in their Business Proposal in accordance with the Solicitation in Section L and as specified in Section J, List of Attachments. The following is additional information and does not include all required information and documentation for the business proposal.

SECTION 1:

1. BUSINESS PROPOSAL TITLE PAGE.

The following must be provided on the first page of the business proposal:

a. Solicitation title and number;

b. Name and address Offeror;

c. Offeror’s DUNS number;

d. Identification of the Proposal Part (Business);

e. Name and telephone number of Business Official;

f. Name of contract administration office (if available);

g. Type of contract action (New contract)

h. Proposed cost; profit or fee; and total; Note: Specific for Sample Task Order 1.

i. Indicate whether you require the use of Government Property in the performance of the contract and if so, what property;

j. Whether your organization is subject to cost accounting standards; whether your organization has submitted a CASB Disclosure Statement, and if it has been determined adequate; whether you have been notified that you are or may be in noncompliance with your Disclosure Statement or CAS, and, if yes, an explanation;

whether any aspect of this proposal is inconsistent with your disclosed practices or applicable CAS, and, if so, an explanation; and whether the proposal is consistent with your established estimating and accounting principles and procedures and FAR Part 31, Cost Principles, and, if not, an explanation;

k. The following statement: This proposal reflects our estimates and/or actual costs as of this date and conforms with the instructions in FAR 15.403 5(b)(1) and Table 15 2. By submitting this proposal, we grant the Contracting Officer and authorized representative(s) the right to examine, at any time before award, those records, which include books, documents, accounting procedures and practices, and other data, regardless of type and form or whether such supporting information is specifically referenced or included in the proposal as the basis for pricing, that will permit an adequate evaluation of the proposed price;

l. Date of Submission; and

m. Name, title and signature of authorized representative.

2. PROPOSAL SUMMARY AND DATA RECORD (NIH-2043); Do not include any Social Security Numbers

(SSNs) on the form.

3. TABLE OF CONTENTS. Include a Table of Contents (TOC) that provides the page number of each proposal section that at a minimum uses the headings and subheadings that appear in the chart above. Additional subheadings may be entered at the Offeror’s discretion. Refer to Other considerations within Section L of the Solicitation.

SECTION 2:

BUSINESS PROPOSAL DISCUSSIONS AND ATTACHMENTS

1. The Offeror should ensure that the business proposal includes all required information and documentation including required attachments in accordance with the Solicitation. The Offeror is strongly encouraged to organize the business proposal in the order listed in the table above.

2. Annual Financial Report This applies to the Prime Offeror. If the Offeror does not have an annual financial report or audited financial statement, provide the most recent balance sheet.

3. Adequate Accounting System (required as Cost-Type Task Orders will be solicited under resultant IDIQ)

a. As per Section L.2.c.9.e., include the required certification,

b. Include the response to the question regarding whether your organization’s accounting system has been approved for use on Government cost reimbursement contracts

c. Provide the Contracting Officer Determination Letter or give the name and address of the agency that approved the system.

d. For cost-type subcontracts proposed, include the subcontractor’s certification and information.

4. Non-Disclosure Agreement for Prospective Offeror Use the link in Section J for Attachment 7 and submit signed form for each named contractor and subcontractor personnel who may have access to non-public information.

5. Small Business Subcontracting Plan

a. Refer to Section L.2.c.6. Small Business Subcontracting Plan for details and use Attachment 13 in Section J of the Solicitation to complete the plan.

b. The plan must be completed based upon the IDIQ Maximum which is $19,990,000and should be listed as the total contract amount in the plan.

c. The percentages proposed must be based on the total IDIQ base value of $19,990,000, not the proposed cost of the Sample Task Order. In other words, the Small business subcontracting Plan percentage goals need to be based on your estimated amount you plan to subcontract over the 5-years period of performance of the IDIQ based upon the assumption that the Offeror would receive $19,990,000 in task order awards. All goals must be estimated and realistic percentages must be calculated against the total IDIQ base value of $19,990,000.

d. Additionally, all goals must meet the minimum HHS current subcontracting goals; these percentages are located on pages 2 and 3 of the Small Business Subcontracting Plan. The HHS current subcontracting goal are listed in L.2.c.6.

e. All costs proposed in the budget (other than the Prime Offeror’s labor) must be considered for small business subcontracting opportunities and the Offeror must provide detailed justification as to why these opportunities cannot be fulfilled by a small business, if not proposed as such.

6. Subcontract Documentation

a. The signed subcontractor commitment letters must be submitted as part of the Technical Proposal and will be evaluated by the Technical Committee. Reference the location of the commitment letters in the business proposal. The remainder of the subcontract documentation must be submitted in the business proposal.

b. As per FAR 44.1 – General, “Subcontract” means any contract as defined in Subpart 2.1 entered into by a subcontractor to furnish supplies or services for performance of a prime contract or a subcontract. It includes but is not limited to purchase orders, and changes and modifications to purchase orders.

c. The Prime must provide the following for each proposed subcontractor:

i. Discussion of determination of responsibility (Refer to FAR 9.104-4).

ii. Confirmation of completion of electronic annual representations and certifications at www.sam.gov

iii. Discussion of how price or cost reasonableness was determined including discussion of adequate price competition or its absence properly justified

iv. Discussion of price/cost analysis of the subcontractor’s cost/price proposal

v. For cost-type subcontracts provide an unsigned Draft Subcontract Agreement; Use of the

Offeror’s standard template including the subcontractor organization’s name, address, type of subcontract, period of performance, amount of subcontract, relevant flowdown clauses, and the subcontractor’s statement of work. Ensure that all required subcontractor flow down clauses are included.

SECTION 2 – COST OR PRICE SUPPORT

Section L of the RFP specifies the minimum documentation requirements for cost data and all cost related support. All related documentation should be included in the proposal in a clearly marked section.

SECTION 3 – UNIFORM COST ASSUMPTIONS

For proposal purposes, the Offeror shall propose based on the following budget assumptions:

1) Labor:

As a baseline, the labor mix required to provide the level-of-effort required for the Sample Task Order shall include the following estimates:

Direct Labor Estimate

Estimated Effort in hours for

Sample Task Order

Principal Investigator 1,080 Section Manager 1 870 Senior Quality Assurance Coordinator 1,040 Senior Chemist 470 Program Manager 470 Information Sys. / Network Security Officer 80 Senior Chemist 470 Staff Chemist 940 Staff Chemist 940 Senior Technical Program Coordinator 1,410 Associate Chemist 940 Associate Chemist 1,880 Assistant Chemist 1,880

Technicians and Support

Principal Technician 1,880 Principal Technician 940 Senior Technician 1,880 Technician 1,880

2) Meetings and Travel:

The following General Cost Assumptions apply to any travel stated in the Sample Task Order Statement of Work (SOW):

a. Assume all airfare to be economy class.

b. Assume two (2) days of travel time for any travel destinations outside of the traveler’s country of origin.

c. Assume hotel and per diem at U.S. Government rates according to the Federal Travel

Regulations (FTR) for the applicable city/location.

Specific Activity Cost Assumptions

1. Domestic Travel The Offeror shall anticipate travel to the NCI to participate in program meetings with the DCP Staff. Anticipate four (4) trips per year for three (3) days each for three (3) (to include the Key Personnel) people to come to the NCI Shady Grove campus in Rockville, MD U.S.A.

2. International Travel The Offeror shall anticipate one (1) international trip per year. For budgeting purposes, use New Delhi, India. Assume two (2) weeks for five (5) (to include the Key Personnel) people per year.

3) Shipping: Pre-clinical in-vivo and in-vitro studies use up to thirty (30) agents per year. These studies require shipping multi-gram quantities of one (1) or more agents to designated user sites. These sites could be located in twenty (20) different geographical areas within the continental U.S. For proposal costing, assume fifteen (15) shipments of one (1) agent each per year from the Offeror’s location to San Francisco, CA and fifteen (15) shipments of one (1) agent each per year from the Offeror’s location to Washington, DC.

4) Agent Purchases (and shipping): Ten (10) to twenty-five (25) new in vitro screening and regulatory toxicology studies are estimated to begin each year requiring milligram to gram quantities of various agents. For proposal costing, assume twenty (20) new studies starting each year, requiring 500 mg of thirty (30) different agents. For proposal costing, assume fifteen (15) shipments of one (1) agent each per year from the Offeror’s location to San Francisco, CA and fifteen (15) shipments of one (1) agent each per year from the Offeror’s location to Washington, DC.

5) Agent Distribution/Shipping: Anticipated clinical trials will require uninterrupted supply of about twenty (20) agents to approximately 100,000 subjects located at approximately fifty (50) different centers throughout the world. Between five (5) to ten (10) new clinical trials per year are anticipated to begin over the next five (5) years. For proposal costing, assume ten (10) shipments per year of clinical-grade agents to each of the following locations: San Francisco, CA; Chicago, IL; Houston; TX; Washington, DC; and Rome, Italy.

6) Bulk Synthesis: Approximately twenty (25) investigational agents per year may require custom synthesis of the bulk material and/or manufacturing into finished dosage forms (tablets and capsules). These agents will be predominantly small molecules with some biotech products as required. The requested amounts of bulk material may range from 1 gram to 1 kilogram and will be of a specified grade and purity. The number of dosage forms may range from 1,000 to 100,000. The finished dosage forms will furthermore be bottled, labeled and packaged into finished products for clinical studies. For the proposal purposes, assume that 50,000 dosages will be synthesized.

7) Analytical Services: NCI/DCP identifies about 25-100 potential chemopreventive agents per year. These candidate agent structures will be forwarded to the Contractor for obtaining and evaluating information regarding agent availability, synthetic feasibility, time to acquisition estimates, source reliability and cost. For proposal costing, assume analysis of fifty (50) agents per year.

8) Drug/agent Acquisitions: The Offeror will be required to purchase and manufacture bulk reagent chemical substances and synthesize drugs.