W81XWH18R00250003_Amendment.docx

W81XWH-18-R-0025

SECTION SF 30 BLOCK 14 CONTINUATION PAGE

SUMMARY OF CHANGES

SECTION F - DELIVERIES OR PERFORMANCE

The following have been modified:

DELIVERABLES

1.0. General Deliverable Information

Delivery Address: All deliverables shall be submitted to the COR designated in the COR appointment letter.

Method of Delivery: Electronic copies shall be delivered using Microsoft Office suite of tools (for example, MS WORD, MS EXCEL, MS POWERPOINT, MS PROJECT, or MS ACCESS format) or in Adobe PDF format, unless otherwise specified by the COR. Electronic submission shall be made via email, unless otherwise agreed to by the COR. This method of delivery also applies to Contract Data Requirement List (CDRL) deliveries.

Shipping: The Contractor shall use appropriate, cGMP-compliant refrigerated shipping carriers for pharmaceutical product shipments (FedEx, World Courier, or similar, as agreed to by the COR), and appropriate shipping methods for all other materials, equipment, and hard copy documents. In the United States, the contractor shall use the US Postal Service standard delivery for delivery of all such shipments.

Government Acceptance Period: The COR will have ten (10) business days to review draft deliverables and make comments. The Contractor shall have five (5) business days to make corrections. Upon receipt of the final deliverables, the COR will have ten (10) business days for final review prior to acceptance or providing documented reasons for non-acceptance. Should the Government fail to complete the review within the review period the deliverable will become acceptable by default, unless prior to the expiration of the ten (10) business days the Government notifies the Contractor in writing to the contrary. The final submission should be deemed approved if the Government has not rejected it in thirty (30) calendar days.

The COR will have the right to reject or require correction of any deficiencies found in the deliverables that are contrary to the information contained in the Contractor’s accepted proposal. In the event of a rejected deliverable, the Contractor will be notified in writing by the COR of the specific reasons for rejection. The Contractor shall have five (5) business days to correct the rejected deliverable and return it per delivery instructions.

The period of performance (POP) shall be up to sixty (60) months from the POP start date.

2.0. Deliverable/Delivery Schedule:

NOTE: For this requirement “deliver” means that the USAMMDA COR is in possession of the deliverable.

A summary of deliverables follows. Copies are to be provided to the Government officials in electronic file unless otherwise stated. Contract Data Requirements List (CDRL) will be incorporated into the contract in CDRL (DD1423) format. If a deliverable due date falls on Saturday or Sunday, the Contractor shall submit the deliverable on the next business day.

Table 1. List of Deliverables

COR (Subsequent)

COR (Subsequent)

COR (Subsequent)

Deliverable 8 (Exhibit A, CDRL A001)

COR (Subsequent)

Deliverable 9 (Exhibit B, CDRL A002)

Deliverable 10 (Exhibit C, CDRL A003)

NLT thirty (30) calendar days after POP start date.

FDA Interactions:

Draft copies of all submissions NLT ten (10) business days prior to FDA submission.

Copies of all meeting documents, communications, inspections and enforcements, and registration and listing concurrently or NLT two (2) business days after occurrence.

Final copies of all submissions concurrently with submission to the FDA.

Follow-up documentation as necessary and within two (2) business days.

FDA Communication Plan:

Updated annually on the 15th calendar day of the contract award month through the end of the POP or within fifteen (15) calendar days of COR request.

FDA Interactions:

Draft copies of all submissions NLT ten (10) business days prior to FDA submission.

Copies of all meeting documents, communications, inspections and enforcements, and registration and listing concurrently or NLT two (2) business days after occurrence.

Final copies of all submissions concurrently with submission to the FDA.

Follow-up documentation as necessary and within two (2) business days.

Must include Government in all FDA communication, both formal and informal.

The Government will review FDA submissions and provide recommendations on these documents within five (5) business days of receiving them.

COR (Subsequent)

Deliverable 12 (Exhibit D, CDRL A004)

COR (Subsequent)

COR (Subsequent)

Deliverable 14 (Exhibit E, CDRL A005)

Deliverable 16 (Exhibit F, CDRL A006)

COR (Subsequent)

3.0 Deliverable Descriptions

Deliverable 1: Kick-Off Meeting Material. The Contractor shall schedule and conduct a Kick-Off meeting in coordination with the Government within ten (10) business days after the start of the contract period of performance. The Contractor and the Government will reach agreement regarding the meeting location after contract award. The meeting may be held at Fort Detrick, MD or the Contractor’s site. The Contractor shall meet with the Government to present an overview of their approach and establish schedules, procedures, and points of contact necessary to conduct the tasks outlined herein. This meeting should not exceed two (2) hours in length. The primary outcome of this meeting is to come to an agreement on the cost, schedule, and performance baselines. The Contractor shall provide the Government with a Kick-Off meeting agenda NLT three (3) business days prior to the meeting. The Contractor shall provide the Government with Kick-Off meeting minutes NLT three (3) business days after the meeting.

Deliverable 2: Project Management Plan (PMP). The PMP shall document how the Contractor will meet and comply with the requirements to control, coordinate, and direct performance, as well as organize and manage resources that will achieve the technical/scientific requirements established in their SOW. The Contractor shall prepare a PMP that includes, but is not limited to, an organization chart, Integrated Management Schedule (IMS), Work Breakdown Structure (WBS), Gantt charts, and security plan that encompasses the entire scope of the contract based on the Government provided Statement of Objectives (SOO). The PMP should consist of control policies and procedures in accordance with standard industry practices for project administration, execution and tracking. The PMP should represent how the Contractor plans to accomplish the entire work scope of this contract and additionally should include, but is not limited to, the following:

1. IMS with identification of milestones where Government information/activity is required and timeline dependencies for subsequent Contractor activities;

1. Description of the Contractor’s overall management approaches, policies, and procedures including suggested project metrics; and,

1. A Staffing Plan that details its approach to selecting, directing, and managing staff and subcontractors to include its approach to overseeing execution of tasks.

The plan shall be used to manage, track and evaluate the Contractor’s performance along with the Government-provided Quality Assurance Surveillance Plan (QASP). The contractor shall provide a revised PMP as a deliverable to the Government if any changes occur to the PMP that was submitted with the proposal.

Deliverable 3: Quality Control Plan (QCP). The QCP shall document how the Contractor will meet and comply with the quality standards established in their SOW. The QCP should include, but is not limited to a self-inspection plan, internal staffing plan, and outline the procedures that the Contractor will use to maintain quality, timeliness, responsiveness, customer satisfaction, and any other requirements set forth in the SOO. The contractor shall provide a revised QCP as a deliverable to the Government if any changes occur to the QCP that was submitted with the proposal.

Deliverable 4: Monthly Progress Report and Meeting Minutes. The contractor shall submit the report for this requirement to the COR with a transmittal letter not to exceed one page. The Report shall highlight major events in the reporting period. The report shall include, but is not limited to details outlining the expenditures and billings to date, projected expenditures and billings, progress, status, any problems/issues encountered, reaching milestones, and completing deliverables as appropriate for the reporting period. The contractor shall require and incorporate input from subcontractors where there are critical or significant tasks. Critical or significant tasks shall be defined by mutual agreement between the Government and contractor. The format for the report shall be agreed upon by the Government and Contractor. The report shall include an updated IMS. Monthly meetings shall be held within seven (7) calendar days after the reports are submitted and /or as requested by the COR with minutes due NLT five (5) business days after the meeting.

Deliverable 5: Spend Plan. The Contractor shall provide a Spend Plan which details how they expect to incur and invoice for costs against the contract. The Spend Plan shall detail costs to be incurred monthly by fiscal year (1 October – 30 September) through the entire POP, starting with proposal submission and, subsequently, monthly with the Monthly Progress Report if there are changes. The Spend Plan total shall match with the total costs proposed for the entire contract in the Cost/Pricing Sheet. The Spend Plan shall be updated as necessary. The Contractor shall report actual progress against the Spend Plan in the Monthly Progress Report.

Deliverable 6: Verification of Contractor Manpower Reporting (CMR) Submission. The contractor shall provide verification of CMR submission to the COR and the Contract Specialist via e-mail. The contractor shall report ALL contractor labor hours (including subcontractor labor hours) required for the development of pharmaceutical interventions for noise-induced hearing loss (PINIHL) via a secure data collection site. The contractor is required to completely fill in all required data fields using the following web address: www.ecmra.mil. Reporting inputs will be for the labor executed during the period of performance during each Government fiscal year (FY), which runs October 1 through September 30. While inputs may be reported any time during the FY, all data shall be reported no later than October 31 of each calendar year, beginning with 2013.

The four Service-specific CMRA systems have been merged into one combined application. All user accounts and system data were transferred to the new consolidated Enterprise Contractor Manpower Reporting Application (ECMRA) at www.ecmra.mil.

Contractors may direct questions to the new ECMRA Support Desk at dod.ecmra.support.desk@mail.mil or obtain detailed instructions from the CMR Contractor Manpower Reporting User Guide available on the new eCMRA website www.ecmra.mil.

The Order Data tab on the CMRA Contractor Data Entry website will ask for the “Requiring Activity Unit Identification Code” (UIC). The Unit Identification Code (UIC) of the Requiring Activity that would be performing the mission if not for the contractor. This is not necessarily the Contracting Office, Contracting Administrative Office, or Funding Source. The UIC is not the same as the Department of Defense Activity Address Code (DODAAC).

The UIC of the Requiring Activity for this contract is W4QFAA - W4QF USAMMDA.

Deliverable 7: Annual Product Review. The Contractor shall participate in an Annual Product Review in-person meeting with US Government personnel either at Fort Detrick, MD or at the Contractor site to review progress and discuss technical issues. The Contractor and the Government will reach agreement regarding the location for each Annual Product Review after contract award. Each review shall provide insight into expenditures, staffing, progress, risks, and status of any Government property, including Contractor-acquired property (if any). The Contractor shall provide project briefings addressing cost/price, schedule, performance, and status of each key element of this contract, noting any problems or risks and alternative and recommended solutions. The Contractor shall provide the Government with a meeting agenda and related materials NLT ten (10) business days prior to the Annual Product Review. The Contractor shall provide the Government with meeting minutes NLT five (5) business days after the Annual Product Review.

Deliverable 8: Clinical Development Plan (CDP). The Contractor shall provide the CDP as defined in Data Item Description (DID) DI-TCSP-82040, section 2.a.(4) in its entirety and in the format outlined in section 1 (Exhibit A, CDRL A001).

Deliverable 9: Regulatory Development Plan (RDP). The Contractor shall provide the RDP as defined in DID DI-TCSP-82040, section 2.a.(2) in its entirety and in the format outlined in section 1 (Exhibit B, CDRL A002).

Deliverable 10: FDA Interactions. The Contractor shall provide documentation related to FDA Interactions as defined in DI-TCSP-82040, section 2.b. in its entirety and in the format outlined in section 1 (Exhibit C, CDRL A003).

Deliverable 11: Commercial Transition Plan (CTP). The Contactor shall provide a CTP that includes, but is not limited to, the commercial marketing analysis, strategy, and plan to demonstrate commercial uses and viability of the product under development, and estimated cost to manufacture and unit price based on projected manufacturing quantities (e.g., 10,000, 100,000, 1,000,000, 10,000,000 units, etc.).

Deliverable 12: Quality Assurance (QA). The Contractor shall provide a plan for Quality Assurance (QA) as defined in DID DI-TCSP-82040, section 2.f. in its entirety and in the format outlined in section 1 (Exhibit D, CDRL A004).

Deliverable 13: Risk Management Plan (RMP). The Contractor shall develop and maintain a Risk Management Plan that highlights potential risks that may arise during the life of the contract, their impact on cost, schedule and performance, and appropriate mitigation plan. This plan should reference relevant Statement of Objectives or Statement of Work elements where appropriate.

Deliverable 14: Clinical Study Protocol. The Contractor shall provide a Clinical Study Protocol as defined in DID DI-TCSP-82040, section 2.d.(1) and in the format outlined in section 1 (Exhibit E, CDRL A005).

Deliverable 15: Interim Analysis Report. The Contractor shall provide an interim analysis report for the Phase 2 clinical study that includes, but is not limited to information on the clinical study progress, results, analysis, and preliminary conclusions. At a minimum, the interim analysis should examine safety, efficacy, and futility of the drug to determine if the study needs to have an altered design or should be halted. The interim analysis period should be designed in the Phase 2 clinical study protocol.

Deliverable 16: Manufacturing Development Plan (MDP). The Contractor shall provide a MDP as defined in DID DI-TCSP-82040, section 2.a.(5) and in the format outlined in section 1 (Exhibit F, CDRL A006).

Deliverable 17: Biostatistics Deliverables. The Contractor shall provide Biostatistics Deliverables as defined in DID DI-TCSP-82040, section 2.d.(5) and in the format outlined in section 1 (Exhibit G, CDRL A007).

Deliverable 18: Trial Master File (TMF) Structure. The Contractor shall provide a TMF structure in International Conference on Harmonisation (ICH) Electronic Common Technical Document (eCTD) format.

Deliverable 19: Clinical Study Report. The contractor shall provide a clinical study report that includes, but is not limited to the clinical study design, results, statistical analysis, discussions, and conclusions. The contractor shall submit the report in ICH eCTD format as required.

Deliverable 20: Contractor Recommended Surveillance. The contractor shall provide its recommended methods of quality surveillance for this requirement in the following format. This information may be utilized by the Government to create a Quality Assurance Surveillance Plan.

*Add or delete rows as necessary.

Deliverable 21: Non-Disclosure/Non-Use Agreement. The Contractor shall sign and submit a Non-Disclosure Statement (Solicitation Attachment 1) on behalf of the company, and shall also ensure that all staff assigned to, including all subcontractors and consultants, or performing on the contract execute and adhere to the terms of the non-disclosure statement, protecting the procurement sensitive information of the Government and the proprietary information of other contractors. Assignment of staff who has not executed this statement or failure to adhere to this statement may constitute default on the part of the Contractor.

Deliverable 22: Issue Summary Report (ISR). The Contactor shall report any significant positive or negative deviation to the schedule or scope of a task immediately to the Government, and the deviation shall be explained within three (3) business days of issue being identified and documented by the Contractor in its Monthly Progress Report.

4.0 Contract Data Requirements List

Table 2. Contract Data Requirements List (CDRL) Contract Line Item Number (CLIN) Contract Data Requirements List

(CDRL)

Description (DID) DID Number & Reference

5.0 Deliverables Schedules Abbreviations

The following abbreviations are used in the deliverable schedules.

Table 3. Contracting Term Abbreviations

(End of deliverables)

SECTION L - INSTRUCTIONS, CONDITIONS AND NOTICES TO BIDDERS

PROPOSAL SUBMISSION

L.1. INTRODUCTION

This section provides general guidance for preparation of proposals as well as specific instructions on the format and content of the proposal. The Offeror’s proposal must include all data and information requested and must be submitted in accordance with these instructions. The proposal shall also be compliant with all requirements as stated in the SOO.

The use of contractor teaming arrangements (as defined in FAR 9.601(1)) and subcontractor relationships are acceptable. Any subcontracting/teaming arrangements contemplated by the Offeror must be presented in detail. The details should disclose those portions of the task which will be subcontracted and the anticipated organizations with which subcontracting or teaming arrangements are planned. Since there is a direct relationship from the Cost/Price proposal to the Management Approach, teaming and functional capabilities, and Past Performance proposal, the Offeror shall cross-reference enough information on subcontracting/teaming arrangements to allow for a thorough proposal review from a technical and management perspective. The Offeror shall include evidence (e.g., statement of intent to enter into a teaming agreement) of subcontractor relationships.

The Offeror shall submit documentation illustrating its approach for satisfying the requirements of this solicitation. Proposals must be clear, coherent, and prepared in sufficient detail for effective evaluation of the Offeror’s proposal against the evaluation criteria. This documentation shall cover all aspects of this solicitation and include the Offeror’s approach for integration and program management activities. Proposals must clearly demonstrate how the Offeror intends to accomplish the project and must include convincing rationale and substantiation of all claims. Unnecessarily elaborate brochures or other presentations beyond those sufficient to present a complete effective response to the solicitation are not desired.

The Offeror shall describe its proposal through the use of graphs, charts, diagrams and narrative in sufficient detail for the Government to understand and evaluate the nature of the approach. In its evaluation and confidence assessment, the Government will consider the degree of substantiation of the proposed approaches in all proposal volumes.

The Offeror’s proposal shall be submitted in electronic format as set forth below.

Offerors’ proposals must include a statement that the proposal shall remain open for a minimum of 150 days from the date of submission.

The Government intends to award without discussions. Therefore, the Offeror’s proposal is presumed to represent the Offeror’s best effort in response to the Solicitation. If discussions are required they will be conducted with Offerors in the competitive range to the extent deemed necessary by the Contracting Officer, in accordance with FAR 15.306. Discussions will be conducted on the content of the proposal and, if discussions have been conducted, a Final Revised Proposal (FRP) will be solicited from those Offerors within the competitive range. A common cut-off date will be established for receipt of all FRPs.

Offerors are prohibited from modifying any documents, printed or electronic, associated with this solicitation and any amendments in any way, shape or form, unless specifically authorized to do so. The electronic solicitation documents posted on http://www.fbo.gov shall be the official documents for this solicitation.

Offers submitted in response to this solicitation shall be in the English language. Offers received in any language other than English shall be determined non-responsive.

If proprietary information in included in a proposal submitted by a contractor, the Contractor shall mark its proposal accordingly (see Section L.2.3).

All proposal information is subject to verification by the Government. Falsification of any proposal submission documents or statements may subject the Offeror to civil or criminal prosecution under Section 1001 of Title 18 of the United States Code.

All Offerors must comply with FAR Clause 52.204-7 System for Award Management (SAM). In complying with this clause, the Offeror must ensure that ALL representations and certifications contained in Solicitation Section K are completed and uploaded to its SAM record at http://www.sam.gov by the date specified for receipt of proposals. Any Offeror that does not have an active SAM record or has a record that does not include all representations and certifications required in Section K may be found non-responsive and may not be considered for award. The NAICS for this requirement is 541715—Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology). Offeror must be registered in SAM under NAICS 541715 in order to be eligible for award. Registration of a new entity in SAM has changed as of 22 March 2018; the registrant must provide an original, signed notarized letter stating that you are the authorized Entity Administrator before your registration will be activated. Registration updates and renewals of existing entities in SAM has also changed as of 27 April. Please visit http://www.sam.gov and https://www.gsa.gov/about-us/organization/federal-acquisition-service/office-of-systems-management/integrated-award-environment-iae/sam-update to learn more about these process changes. Please note that international entities must follow a different process. It is recommended that Offerors allow sufficient time to complete the SAM registration process. An entity can be registered in SAM under multiple NAICS if they are applicable to the entity’s business.

Any data previously submitted in response to another solicitation to USAMRAA or another agency shall be assumed to be unavailable during this proposal evaluation and source selection process. Proposal data shall not be incorporated into this proposal by referring to another proposal or other source.

The Government will not reimburse any Offerors for costs incurred as a result of preparation and submission of a proposal in response to this solicitation.

L.2. PROPOSAL FORMAT

L.2.1. Proposal Format

The Offeror shall provide their proposal in electronic format as noted below. It shall include the Technical Approach, Regulatory Approach, Management Approach, Experience, Past Performance information, Section K Representations and Certifications, and Cost/Price data submitted in its proposal. All electronic proposal documents shall be in searchable Adobe (.pdf) format compatible with Adobe Acrobat XI Pro, except for the Cost Proposal Spreadsheet, which shall be in Excel (.xls) format. The Cost/Price proposal shall be submitted in MS Excel 2003 or higher, but not greater than MS Excel 2010 format. The firewall utilized by the Government contracting office does not authorize or accept zip files. The proposal shall be submitted in Times New Roman, size 11, with 1-inch margins. Mandatory font size is not applicable to figures and/or charts.

Legible tables, charts, graphs, and figures shall be used wherever practical to depict organizations, systems and layout, implementation schedules, plans, etc. These displays shall be uncomplicated, legible, and shall not exceed 11 x 17 inches in size. The 11 x 17 pages may only be used for large tables, charts, graphs, diagrams and schematics, not for pages of text. For tables, charts, graphs and figures, the text shall be no smaller than 10-point font.

EXCEPTION – SPECIAL FORMATTING INSTRUCTIONS FOR THE STATEMENT OF WORK (SOW): The SOW shall follow unique formatting so that it will not create any errors when it is incorporated into the Government’s contract writing system. The SOW shall be in Times New Roman font, size 10 and shall not contain a table of contents or any images imbedded into the document. Only basic tables with single, thin borders and no shaded cells created in Microsoft Word are accepted. The font must be black without any highlighting with 1-inch margins. Text must be left-aligned.

If requested, revisions shall be submitted with revised text in readily identifiable print (e.g., boldface or underlines) and line bar in margin. Revised pages shall be numbered, dated, and submitted in the same format specified herein. Narrative explanations are not acceptable other than as replacement pages. The Government will reevaluate only those changed portions.

File Size: The Government's recommended maximum size for email attachments is 10MB. The maximum size limit applies to one large attachment or the sum total size of several attachments included in a single email. The Government's recommendation for Offeror's submitting attachments that are larger than 10MB is to use the U. S. Army Aviation and Missile Research Development and Engineering Center (AMRDEC) Safe Access File Exchange (SAFE). AMRDEC SAFE provides an alternative way to send files other than email and supports file sizes up to 2GB. AMRDEC SAFE can be accessed via the following URL: https://safe.amrdec.army.mil/safe/Welcome.aspx

Page Limits: Proposal pages are limited to those stated in the chart below. All pages of each volume shall be numbered by section and dated. For any sections of a proposal with a defined page limit, pages exceeding the specified limit will be removed and not forwarded for evaluation. Failure to submit all documents concurrently and in accordance with these instructions may result in elimination from further consideration and evaluation.

The overall proposal shall consist of four (4) separate and distinct volumes. Each volume shall be appropriately titled and include the solicitation number. The page limits of each proposal volume are as follows:

Volume

Volume

Regulatory Approach

Management Approach

Experience

Performance Volume

Proposal Volume

L.2.2. General Volume Content

To the greatest extent possible, each volume of the proposal shall be written on a standalone basis so that its content may be evaluated with a minimum of cross-referencing to other sections of the proposal. Information required for proposal evaluation which is not found in its designated volume or section will be assumed to have been omitted from the proposal.

The information in each volume should be specific and complete. The proposal shall be in a clear, concise form, presenting complete, effective methods and approaches for satisfying the requirements. It shall be in sufficient detail to reflect a complete understanding of the work to be accomplished and permit a thorough analysis. Responses will be evaluated as outlined in Section M, Evaluation Factors for Award. All of the requirements specified in the solicitation are mandatory. By submitting a proposal, the Offeror represents that its firm will be responsible for meeting the requirements specified in the solicitation. It is not necessary or desirable for the Offeror to restate this in its proposal. Do not merely reiterate the objectives or reformulate the requirements specified in the solicitation.

All cost information shall be addressed ONLY in the Cost Proposal Volume. Do not address cost/price in any other Volume.

L.2.3. Confidential Information

The Freedom of Information Act (FOIA) and its amendments have resulted in an increasing number of requests from outside the Government for copies of contract qualifications and proposals submitted to federal agencies. If an Offeror’s submissions contain information that it believes should be withheld from such requestors under FOIA on the grounds that they contain “trade secrets and commercial or financial information” [5 USC§552(b)(4)], the Offeror should mark its submissions in the following manner:

The following notice should be placed on the title page: “Some parts of this document, as identified on individual pages, are considered by the submitter to be privileged or confidential trade secrets or commercial or financial information not subject to mandatory disclosure under the Freedom of Information Act. Material considered privileged or confidential on such grounds is contained on page(s) _______.”

Each individual item considered privileged or confidential under FOIA should be marked with the following notice: “The data or information is considered confidential or privileged, and is not subject to mandatory disclosure under the Freedom of Information Act.”

L.3. CONTENT INSTRUCTIONS

L.3.1. Volume I Contents – Administrative Volume

L.3.1.1. SF33 Cover Page

The Offeror shall fill out page 1 of the Solicitation Form (SF) 33, Solicitation, Offer and Award. The Offeror shall fill out blocks 12 through 19 accordingly:

The Government requires a minimum acceptance period of not less than 150 calendar days. The Offeror shall complete Block 12 with full cognizance of the minimum acceptance period of 150 calendar days. “Acceptance Period” means the number of calendar days available to the Government for awarding a contract from the date specified in this solicitation for receipt of an offer. The offer may specify for a longer acceptance period than the Government’s minimum requirement but shall not specify a shorter period.

If any amendments to the solicitation are issued, the Offeror must acknowledge each amendment number and date in Block 14 of the SF 33. Failure to acknowledge all solicitation amendments may render the Offeror non-responsive.

The Offeror’s legal name and address in Block 15A on the SF33 must match the information for the Offeror in SAM.gov at http://www.sam.gov including the corresponding Commercial and Government Entity (CAGE) code number and Data Universal Numbering System (DUNS) number (Note: the address listed in Block 15A will be the official mailing address used by the Government for letter correspondence, if necessary).

The name, title, signature and date identified in Blocks 16, 17 and 18 must be an authorized representative with authority to commit the Offeror to contractual obligation.

L.3.1.2. Executive Summary of the Overall Proposal

The Offeror shall include an Executive Summary describing the overall proposal and company approach to fulfill this requirement, excluding cost information.

L.3.1.3. Representations, Certifications and Other Statements of Offerors (Solicitation Section K)

The Offeror shall complete and submit the required information in Section K of this solicitation for the listed provisions as part of the Administrative Volume. Failure to submit, complete, or sign the required representations, certifications and other statements may render the Offer ineligible for award.

(1) Annual representations and certifications IAW 52.204-8.

(2) Ownership or control of offeror IAW 52.204-17.

(3) Predecessor of offeror IAW 52.204-20.

(4) Information regarding responsibility matters IAW 52.209-7.

(5) Representation by corporations regarding delinquent tax liability or a felony conviction under any Federal law IAW 52.209-11.

(6) Public disclosure of greenhouse gas emissions and reduction goals representation IAW 52.223-22.

(7) Cost accounting standards notices and certification IAW 52.230-1

(8) Proposal disclosure—cost accounting practice changes IAW 52.230-7.

(9) Annual representations and certifications (Alternate A) IAW 252.204-7007.

(10) Proposal adequacy checklist IAW 252.215-7009.

(11) Identification and assertion of use, release, or disclosure restrictions IAW 252.227-7017

(12) Identification of technical data previously delivered to the Government IAW 252.227-7028. If no technical data or computer software has previously been delivered to the Government, the Offeror must still address the requirement of the clause by submitting a statement. Failure to do so may render the Offeror proposal ineligible for award.

L.3.1.4. Organizational Conflict of Interest Certification and/or Mitigation Plan

The Offeror shall complete the attached OCI Certification (Solicitation Attachment 2) and provide (if necessary) an OCI Avoidance or Mitigation Plan.

L.3.2. Volume II Contents – Technical Volume

L.3.2.1. Cover Page

The cover page shall identify the Solicitation number, Offeror name and mailing address, Point of Contact (POC) name, and contact information. The Offeror shall provide a POC who is authorized to hold discussions/negotiations with the Government and has the full authority to bind the Offeror to a contract. Information required includes: First name, last name, title, e-mail address, phone number, Fax number, and level of authority.

L.3.2.2. Executive Summary of the Technical Volume, Table of Contents, and Glossary

The Offeror shall provide an executive summary to include a concise narrative summary of the volume, including significant risks, and a highlight of any key or unique features, excluding cost/price. The salient features should tie in with Section M Evaluation Factors for Award. Any summary material presented here shall not be considered as meeting the requirements for any portions of other sections of the proposal. A glossary of abbreviations or acronyms shall be included in the volume.

L.3.2.3. Technical Approach

The Offeror shall submit a written technical approach that effectively demonstrates a clear understanding of all the tasks to be performed, the methodology and flexibility that will be utilized, and how the approach will accomplish all tasks, subtasks, and administrative tasks necessary to ensure program success. The Offeror shall describe, in detail, its technical approach and overall ability to perform the stated Government tasks and objectives in section 3.0 of the SOO. The Offeror shall effectively demonstrate a clear working knowledge of pharmaceutical development and manufacturing.

The Offeror shall effectively demonstrate how it will yield success and manage or reduce risk (cost, technical or schedule) to the Government.

The Offeror shall identify intellectual property ownership, describe any appropriate intellectual and material property plan with other organizations (if appropriate), and address any impact of intellectual property issues on product development.

The Offeror shall submit the following as part of the proposed Technical Approach:

L.3.2.3.1. Statement of Work

The Offeror shall provide a Statement of Work (SOW) as part of the Technical Volume. The SOW should be consistent with the Offeror’s technical approach and the Government’s SOO. The SOW will be incorporated into the contract by full text and should provide greater detail than the Technical Approach and demonstrate how the technical approach is to be accomplished in a task-oriented and timely manner to successfully produce and deliver a product as described in the Government’s stated objectives. The SOW will be used to create a Quality Assurance Surveillance Plan (QASP) post-award.

L.3.2.3.2. Proposed Level of Effort

The Offeror shall complete the Proposed Level of Effort Template (Solicitation Attachment 3) as part of the Technical Volume. The Offeror shall propose the level of effort that is appropriate for its technical approach. The Offeror shall provide a listing of the labor categories to be utilized and the levels of effort proposed for each labor category. Labor categories and levels of effort shall be proposed for the Prime contractor as well as its subcontractor(s). The proposed level of effort should include a reference to the Offeror’s SOW section(s) each labor category is proposed for. Levels of effort shall be in terms of hours and full time equivalents for the duration of the period of performance. Levels of effort should not include cost information (i.e., labor category rates or labor costs).

L.3.2.3.3. Clinical Development Plan

The Offeror shall provide a Clinical Development Plan (CDP) as part of the Technical Volume. The CDP shall describe the goals and objectives of the clinical program for the drug/biologic. This plan should include, but is not limited to: background; scientific summary; target population; PK/PD; mechanism of action; side-effects; a list of any/all clinical studies planned or completed including any objectives/endpoints; letters of reference; rights of reference; and a schedule of deadlines for milestones and decision making (go/no go); and any associated risks. The CDP should also describe:

(a) how the clinical plan will support the regulatory strategy and/or RDP.

(b) the clinical trial agreement and approval process.

In addition, the Offeror shall include a Statistical Analysis Plan that describes the study design and planned analyses to support and accomplish the clinical trial objectives.

L.3.2.3.4. Commercial Transition Plan

The Offeror shall provide a Commercial Transition Plan (CTP) as part of the Technical Volume. The CTP should include, but is not limited to, the commercial marketing analysis, strategy, and plan to demonstrate commercial uses and viability of the product under development, and estimated cost to manufacture and unit price based on projected manufacturing quantities (e.g., 10,000, 100,000, 1,000,000, 10,000,000 units, etc.).

L.3.2.3.5. Manufacturing Development Plan

The Offeror shall provide a Manufacturing Development Plan (MDP) as part of the Technical Volume. The MDP shall describe the manufacturing process for the drug/biologic product to ensure conformity with §501(a)(2)(B) of the Food, Drug, and Cosmetics Act (FD&C Act, Title 21 United States Code (USC) §351 (a)(2)(B)), regarding good manufacturing practices (GMP). This plan should describe, but is not limited to, planned or completed drug substance studies; list of excipients and information to support the safety of excipients that, when appropriate, shall be cross-referenced; drug product and formulation development summary from initial concept through final design; physicochemical and biological properties; manufacturing process development and validation program documents; container closure system documents [description, choice, rationale]; microbiological attributes documents and plans; compatibility documents (e.g., precipitation); assay development and validation, stability plan; and any associated risks.

L.3.2.4. Regulatory Approach

The Offeror shall provide a Regulatory Strategy (RS) that demonstrates the feasibility of the proposed technical approach to accomplish the SOO. The RS shall describe the regulatory pathway for FDA regulatory approval/licensure and any possible post-marketing commitments. The Offeror shall describe the target product profile or equivalent that can be used throughout the development process that will describe how a product will be utilized by the end user. This product profile shall include, but is not limited to: indication and usage; dosage and administration; dose forms and strengths; contraindications; warning and precautions; safety adverse reactions, drug interactions; use in specific populations; drug abuse and dependence/overdose; description of drug; clinical/pharmaceutical; pre-clinical toxicology; clinical studies; references; storage and handling; patient counseling; risk evaluation mitigation strategy; and supporting documentation and/or templates as appropriate.

The Offeror shall demonstrate a clear working knowledge of medical product development, clinical study management, pharmaceutical manufacturing, and applicable regulatory requirements.

The Offeror shall identify appropriate potential regulatory risks associated with the proposed product and a practical mitigation strategy for possible complications.

The Offeror shall demonstrate evidence of satisfactory regulatory-compliance throughout the product development cycle: Capacity to manage processes associated with all stages of product development, including but not limited to sponsor responsibilities for IND applications; GMP- compliant manufacturing; GLP and GCP-compliant- investigations; adverse event reporting; pharmaceutical product labeling; and reporting requirements.

The Offeror shall demonstrate evidence of a regulatory and quality program, including team(s), and/or…