SOW_for_SBIR_STTR_CAP.doc

STATEMENT OF WORK

The National Institutes of Health

Commercialization Assistance Program (NIH-CAP)

For NIH SBIR and STTR Phase II Awardees NAICS Code: 541611 (Dated: 11/26/2013) The purpose of the National Institutes of Health (NIH) Commercialization Assistance Program (CAP) is to help NIH Small Business Innovative Research (SBIR) and Small Business Technology Transfer (STTR) Phase II awardees accelerate the transition of their NIH-funded technologies under the SBIR and STTR programs into the marketplace. CAP is designed to provide participants with individualized assistance toward accomplishing the following goals:

· Developing or improving strategic business planning

· Developing or improving market identification, definition, and research capabilities

· Developing or improving marketing materials

· Developing a roadmap for and establishing licensing opportunities

· Developing a roadmap for and establish strategic and/or investment partnerships

· Seeking regulatory and/or reimbursement approvals

CAP is a mentoring and training program that includes one-on-one business counseling organized around topics that will contribute to the development of a strategic action plan, business plan, or a licensing or go-to-market strategy. Additionally, the CAP seeks to provide robust strategic and technical assistance to program participants seeking help with the Food and Drug Administration (FDA) regulatory and approval processes, typically representing a significant proportion of companies funded by the NIH SBIR and STTR programs.

Program Summary

Small business participation in the training activities will span a period of nine (9) months with a targeted start date in January 2014. The program shall be customized to meet the needs of early stage or advanced companies and be divided into three: (1) an emerging track, (2) an advanced track, and 3) a regulatory track. The emerging track will be comprised of training and informational workshops and individual (one-on-one) mentoring and consulting sessions led by an advisor assigned by the contractor. The advanced track will focus on the completion of task(s) specifically designed to assist the more advanced business savvy companies with overcoming critical issues that are hindering their commercialization progress. The regulatory and reimbursement track will provide individual (one-on-one) mentoring and consulting sessions led by an advisor assigned by the contractor aimed at helping companies navigate the Federal regulatory pathway and reimbursement approval processes.

CAP participation is at no direct charge to the selected companies; however, participants are responsible for their travel and lodging expenses associated with attending CAP-related events. Eighty (80) companies in total will be selected to participate. However, given the anticipated rate of attrition, the number of participants could decrease. Companies will be assigned into an appropriate track based on their needs and commercialization readiness upon application review conducted jointly by the NIH and the selected Contractor.

EMERGING TRACK SPECIFICS:

Over a nine-month period, participants will:

· Participate in an initial kickoff workshop

· Participate in virtual webinars

· Work closely on a regular, monthly basis with the selected Contractor on the company’s business and commercialization strategic plan or process

· Develop a management toolkit, or set of customized materials that may be used in commercialization efforts

· Participate in a feedback workshop that allows for constructive criticisms about the participant’s commercialization strategy

· Participate in a Next Steps/Closeout Meeting at which time participants will present their 18-month Strategic Action Plans to NIH

· Provide program feedback and commercialization progress tracking reports to NIH

ADVANCED TRACK SPECIFICS:

Over a nine-month or less period, participants will:

· Participate in a kickoff workshop

· Identify one or two specific outcomes that are achievable within the program’s timeframe and resources.

· Upon NIH approval of targeted outcomes, each participant will work one-on-one with a designated advisor and other business experts as needed to achieve the desired commercialization outcome

· Participate in virtual webinars

· When appropriate, present their business opportunity at an outside partnering/investment event

· Upon completion of their targeted outcomes, provide a close-out webinar presentation to NIH on achieved outcomes and strategies for carrying their technology forward.

· Provide program feedback and commercialization progress tracking reports to NIH.

REGULATORY TRACK SPECIFICS:

Over a nine-month or less period, participants will:

· Participate in a kickoff workshop

· Identify one or two specific outcomes that are achievable within the program’s timeframe and resources.

· Upon NIH approval of targeted outcomes, each participant will work one-on-one with a designated advisor and other business experts as needed to achieve the desired commercialization outcome related to the FDA approval process

· Participate in virtual webinars

· Upon completion of their targeted outcomes, provide a close-out webinar presentation to NIH on achieved outcomes and strategies for carrying their technology forward.

· Provide program feedback and commercialization progress tracking reports to NIH.

Period of Performance:

One year from award date with four (4) additional one-year option periods.

DELIVERABLES:

TASK 1: Develop a web-based project management system that (1) accepts applications from interested participants, and (2) tracks program participants’ progress.

The Contractor will establish a secure web-based project management system that will document the progress of each CAP participant. The system should also have the ability to accept on-line applications from those interested in applying to the program. The system must be accessible by both the Contractor and the National Institutes of Health and the Contractor will be responsible for any adjustments deemed necessary by the COR. Upon the completion of the CAP, all program-related and developed materials are to be uploaded and the system turned over to NIH for retention.

TASK 2: Evaluate applications and recommend participants to NIH.

NIH will notify its SBIR and STTR Phase II award recipients funded in the past five (5) years of the opportunity to participate in this program, however, priority will be given to new applicants. The Contractor shall develop an on-line application process for interested prospective participants. The Contractor shall review and evaluate the applications and forward their recommendations to NIH for consideration. NIH will then make the final selection of 80 participants and assignments to one of the three tracks.

Participants:

· Selected companies must meet the current SBIR/STTR eligibility requirements and have received an NIH SBIR or STTR Phase II or a Fast-Track award (grant, contract, or cooperative agreement) in the past five (5) years. NIH will verify the eligibility of each applicant.

· The technology targeted for commercialization in the CAP must have been developed with an NIH SBIR or STTR Phase II award.

· It is expected that participants may be at different points along the commercialization spectrum, and therefore individualized technical assistance must be offered to each participant by an advisor provided by the Contractor. Participants will include both “emerging companies” (those making their first debut into the commercial marketplace) and “seasoned companies” (those who may have some experience and/or track record with commercialization). The Contractor must have the expertise to handle this wide range of commercialization experience and assist the companies with identifying the most appropriate strategy for commercialization.

· NIH supports a wide range of biomedical and health science technologies including the development of clinical technologies, basic research tools, and healthcare/IT type products. The Contractor shall demonstrate a substantial understanding of the diversity of the NIH SBIR/ STTR funded technologies and must have the ability to provide commercialization assistance for the entire range.

· The program is designed for those seeking investments, strategic alliances, licensing deals, business strategy, or regulatory and reimbursement guidance. The program is not intended for those companies seeking only sales, contacts prospects, or business development. Accordingly, each applicant will be expected to provide as part of the application an executive summary outlining core business operations, company vision, business strategy to date and key challenges to be addressed in the CAP.

Task 3: Develop and coordinate the “Kickoff Workshop” (All tracks)

The Kickoff Workshop is the first of two CAP-sponsored events for all participants. The Contractor shall develop and coordinate this 2-day in-person workshop. The workshop will be held at a single location at a date to be determined by the NIH Project Officer. The workshop will enable participants to meet with their assigned advisor, network with fellow CAP participants, meet other key NIH and industry people who may be associated with the program, and attend commercialization training seminars. Seminar topics may include but are not limited to the following:

· An Introduction to the NIH CAP Program

· Intellectual Property Management

· Financing Life Science Companies

· Strategic Alliances and Partnerships

· Strategic Business Planning

· Navigating the FDA regulatory process

· Reimbursement considerations and strategies

· Leveraging Social Media and Networking

· Marketing Your Company: Putting Your Best Foot Forward

· CEO Roundtable: Commercialization Success Stories from previous Cap participants

· Understanding your customer

· Session Targeting Healthcare IT/Education /Media Companies

[NOTE: Please be advised on the HHS Policy on Efficient Spending (below)] Task 4: Work one-on-one with emerging track program participants to: (1) provide business and strategic planning; (2) develop a management toolkit; and (3) connect participants with potential partners and/or investors. (Emerging track only)

Business and Strategic Planning: During the Business and Strategic Planning phase, the Contractor shall provide an advisor to work one-on-one on a regular basis with each of the participants to develop or tease out their business model, improve or enhance their understanding of the target market (the “addressable market”), create a strategic action plan (including possible timelines), and develop some of the necessary marketing materials to implement the strategy. Participants may work with their advisors to identify potential partners, licensees and/or investors and develop an approach on making the proper connections at the right time. Participants will be coached and mentored at face-to-face meetings or via remote communication tools, e.g., phone, email, Internet.

A get-to-know, two-hour face-to-face meeting between each participant and their advisor will be scheduled early in the program. Depending on the logistics, this may be done prior to attending the kickoff workshop or at the workshop itself. The meeting will include an in-depth discussion of the company’s status, suitability of the CAP, commercialization needs, and a work plan. By the end of this meeting, the Contractor shall have communicated a clear understanding of all program details, a customized commercialization approach, and obtained a firm commitment from the selected participant to invest the required time and effort to the CAP. Note that advisors are not to do the work for the participants, but will mentor, guide, and assist.

At the end of the business and strategic planning phase of the CAP, each participant is expected to have a solid understanding of the commercial value of their technology, how it fits in to the current market landscape (positioning), the technology’s competitive advantage, what gaps remain to be addressed, a plan to address such gaps, and the optimal strategy for achieving the previously-identified goals. In addition, and if appropriate, participants may develop with their advisors’ assistance, a set of specific strategic or investment targets and a list of realistic prospects that the participants may wish to approach.

Management Toolkit: During the Business and Strategic Planning Phase of the program, the Contractor shall assist each participant with the development of a Management Toolkit that will include materials useful for implementing the commercialization plan both during and after the program ends. Because it will be customized for each participant’s needs, it may include any number of the following components:

1. Road Show Presentation: This is a short PowerPoint presentation to “pitch” the company to potential investors, strategic partners or licensees. It will provide a brief, but informative and compelling glimpse of the company, to attract the interest of a targeted audience at events such as investment forums, conferences, or trade.

2. Business Case Presentation: This is a comprehensive, in-depth PowerPoint presentation of the company’s intellectual property, technology, product/service, value proposition, customer base, financials, management team, and other important features of the company. The goal of the Business Case Presentation is to provide an audience with a detailed overview of the company and may also be used for one-on-one meetings with prospective partners and/or investors.

3. Virtual Showcase Materials: A virtual on-line showcase will be set up to market the business opportunities and technologies of all CAP participants. The materials may be posted on an NIH website in the form of a quad chart and may include the specific business opportunity, a company description, and a brief description of the product and its current state of development. These materials may also be used by the company for their marketing endeavors both during and after the CAP.

4. Strategic Action Plan: At the end of the program, each company will have a list of strategic tasks and milestones with a timeline looking forward for the next 18 months. This tool is meant for managing and tracking the participant’s commercialization progress and successful outcomes after the CAP.

Connecting with Potential Investors, Strategic Partners and Licensees: Preparing for and accessing investors, licensees and strategic partners is an important element of the program and will be emphasized throughout the course of CAP. The Contractor shall solicit “Wish lists” of potential strategic partners and investors from the participating companies when CAP begins and as stated previously, the Contractor shall help prepare a roadmap and tools to assist CAP participants in approaching them. The Contractor may also help in identifying new investors, licensees and partners.

If a participant is ready and the Contractor is able to garner the interest of desired investors, licensees and partners, the Contractor shall help the participant approach them. These introductions are to be made only if a participating company is truly ready and only if the Contractor has reason to believe the potential partners, licensees and investors are appropriate, as contacting potential partners and investors too early or inappropriately may be detrimental to the participant’s future prospects with these resources. The Contractor’s advisors shall counsel the participants regarding the best possible time to approach. The Contractor shall coordinate scheduling close-out presentations and ensure participation of appropriate advisors and mentors at the end of the program.

Task 5: Provide individualized mentoring for advanced track participants only

An advisor/mentor who will serve as a facilitator and aide and as a sounding board for the participants is to be assigned to each of the fifteen advanced track participants. With the assistance of the advisor/mentor, a work plan will be documented describing the participant’s most critical commercialization need/gap and the desired outcome that is deemed to be possible during the program. This document will guide the course of work to be performed by the participant and their advisor/mentor. Experts in business areas such as accounting, FDA and CMS processes, or intellectual property protection will be brought in as needed to assist the participant and their advisor//mentor. The Contractor shall facilitate such connections with industry experts for up to 5 hours of pro bono counseling by each expert. Because each strategic plan will be unique and participant-specific, participants may spend varying amounts of time working toward their desired outcome. Some may complete the program in perhaps only a few months while others may be working toward their outcome until the scheduled program completion in September.

Connecting with Potential Investors, Strategic Partners and Licensees: Preparing for and accessing investors, licensees and strategic partners is an important element of the program and will be emphasized throughout the course of CAP. The Contractor shall solicit “Wish lists” of potential strategic partners and investors from the participating companies when CAP begins and as stated previously, the Contractor shall help prepare a roadmap and tools to assist CAP participants in approaching them. The Contractor may also help in identifying new investors, licensees and partners.

If a participant is ready and the Contractor is able to garner the interest of desired investors, licensees and partners, the Contractor shall help the participant approach them. These introductions are to be made only if a participating company is truly ready and only if the Contractor has reason to believe the potential partners, licensees and investors are appropriate, as contacting potential partners and investors too early or inappropriately may be detrimental to the participant’s future prospects with these resources. The Contractor’s advisors shall counsel the participants regarding the best possible time to approach.

When the desired outcomes are completed, each advanced track company will present to NIH strategic outcomes accomplished in the program including a timeline looking forward for the next 18 months. This tool is meant for managing and tracking the participant’s commercialization progress and successful outcomes after the CAP. The Contractor shall coordinate scheduling close-out presentations and ensure participation of appropriate advisors and mentors.

A final report for each participant will be prepared and uploaded into the project management system. This report will include the companies’ progress, their end results, and comments concerning if the desired outcome was reached. If not reached, the key issues that prevented the outcome from occurring are to be included.

Task 6: Provide individualized mentoring for regulatory track participants only

An advisor/mentor who will serve as a facilitator and aide and as a sounding board for the participants is to be assigned to each participant in the regulatory track. With the assistance of the advisor/mentor, a work plan will be documented describing the participant’s most critical and desired outcome that is deemed to be possible during the program that relates to the Food and Drug Administration (FDA) approval process. This document will guide the course of work to be performed by the participant and their advisor/mentor. Experts in business areas such as accounting, FDA and CMS processes, or intellectual property protection will be brought in as needed to assist the participant and their advisor//mentor. The Contractor shall facilitate such connections with industry experts for up to 15 hours of pro bono counseling by each expert. Because each strategic plan will be unique and participant-specific, participants may spend varying amounts of time working toward their desired outcome. Some may complete the program in perhaps only a few months while others may be working toward their outcome until the scheduled program completion.

Assistance provided by the advisor/ mentor may include but are not limited to:

· Identification of the company’s goals for its product – based on discussion with the company, the advisor/ mentor will assess what is the company’s expected product, its intended use and indications for use.

· Identification of the regulatory path –based on the company’s goal(s), the advisor/ mentor will recommend a specific regulatory path that should be taken. This will be applicable also to companies that have previously submitted materials to the FDA, received rejection or otherwise encountered challenges with their path to submission or approval.

· Development of regulatory strategy – the advisor/ mentor will work with the company to address regulatory hurdles the company will likely face given its product, the regulatory path and the company’s current approach to navigating the regulatory landscape.

· Assessment of the success of the chosen regulatory path- the Contractor shall devise metrics to be used for assessment for the likelihood of the success of the recommended regulatory path.

Task 7: Develop and lead the feedback workshop(s)

The feedback workshop is the second CAP-sponsored event, however requires in-person participation from the companies. A minimum of two regional feedback workshops will be organized and led by the Contractor at locations based on the demographics of the participants. The Contractor shall develop and lead this feedback workshop which is comprised of scheduled closed business meetings between the company and industry experts. To accommodate travel preferences of the participating companies and also to cultivate local networking, CAP feedback workshops may be held in several locations including Washington, DC.

Participants are required to attend only one day at one location. Each will be scheduled for a 2-hour meeting where the company will present their business opportunity to a group of mentors and life science industry experts who will provide honest and objective feedback of the company’s commercialization strategy and pathway. They will also critique the presentation for content and presentation style. The Contractor is responsible for assuring that appropriate mentors and industry experts will be available for each meeting.

Task 8: Provide written and oral program progress reports.

Written Reports—Progress and final reports will be provided in writing by the Contractor to the NIH SBIR Project Officer. Monthly progress reports will be due on the 8th of each month, and will be approved/disapproved by the NIH SBIR Project Officer within five business days. Any deficiencies shall be corrected by the Contractor and resubmitted within five business days. These reports shall include, but are not limited to, details of work completed, problems encountered,steps taken to resolve the problems, and any other pertinent issues and concerns.

Upon completion of the program, the Contractor shall prepare a final report that will include a summary of the progress and actions taken during the program as well as suggestions for improving the program. The final report will be submitted in accordance with the same guidelines as the monthly reports.

Oral Presentations—The Contractor will come to the NIH campus a minimum of once during the program to give a presentation on the program and its progress. The date will be negotiated with NIH SBIR Project Officer but depending on the need, will be either during the latter part of the business and strategic planning portion of the program, or at the conclusion of the program.

Task 9: Track participants’ commercialization progress and provide statistical analysis of results.

Throughout the course of the program, the Contractor shall track and collect commercialization data from the participants from the beginning to the completion of the program.

Collected data must include but are not limited to investor/partnership/licensing introductory activities, changes to overall business strategy or components thereof, progress toward securing strategic investments or alliances, activities toward developing a comprehensive regulatory or reimbursement plan, and whether the program was perceived to have impacted the companies’ commercialization progress. For those companies choosing to commercialize without third party involvements, data will also be collected concerning their sales volume related to the CAP project, and whether any debt was incurred in order to further commercialization.

The Contractor shall analyze the statistical data and provide written summary report for each participating company indicating if there was commercialization progress as part of the final progress report described in Task 8. The Contractor must, therefore, have the expertise to conduct statistical analysis and strong writing skills required in compiling the company-specific commercialization tracking reports. The Contractor will provide these reports to NIH before the end of the contract base year and, thereafter, before the end of each subsequent option years 1, 2, 3, and 4 of the contract.

Advanced Understandings:

In general, the Contractor will be expected to provide timely responses to CAP-related inquiries from the Project Officer and participating companies.

Program Timeline Based on Deliverables and Program Milestones

Example 12-month Base Year of CAP (in months)

Deliverable/

Task #

Tasks 3, 4, 5, 6, 8

Tasks 7, 8

Tasks 4, 5, 6, 8 Tasks 8, 9

Miscellaneous

The contractor is encouraged to collaborate with state organizations and other independent programs, when appropriate, to provide the largest range of opportunities in commercialization training to the small businesses.

Confidentiality of Information

In accordance with FAR 52.227-14(b), the contractor shall guarantee strict confidentiality of the information/data that it is provided by the Government during the performance of the contract. The Government has determined that the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature and cannot be disclosed in any manner.

The Contractor, in whole or in part, can only make disclosure of the information/data, after the Contractor receives prior written approval from the Contracting Officer. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the Contracting Officer.

Due to the confidential nature of the participants’ business information to which the Contractor will be exposed, each Contractor Personnel must sign a confidentiality agreement that states Contract Personnel will not share information concerning the CAP participating small business with anyone other than NIH personnel, other Contractor employees, or the participating small business unless agreed to by the participating small business. These agreements will remain on file with the NIH. In addition, the Contractor will enter into confidentiality agreements directly with the participating small businesses.

Disclaimer

The Department has developed new policies on the use of appropriated funds for: conferences and meeting space, food, extraneous promotional items, and printing and publications.

These policies support the Executive Order on Promoting Efficient Spending (EO 13589); the Executive Order on Delivering an Efficient, Effective, and Accountable Government (EO 13576); and Office of Management and Budget Memorandum on Eliminating Excess Conference Spending and Promoting Efficiency in Government (M-35-11). The policies also promote the Department’s commitment to comply with appropriations law and act in a fiscally responsible manner by minimizing our administrative costs to perform our mission critical functions in the most efficient, cost effective way.

The policies are effective immediately and apply to all new obligations and all funds appropriated by Congress (whether from an annual appropriation, multi-year appropriation, appropriated user fee, mandatory appropriation, gift funds, or reimbursements from such appropriations, etc.).

It is the Department’s policy that the conferences it funds shall be consistent with legal requirements and HHS’ missions, objectives, and policies; represent an efficient and effective use of taxpayer funds; and be able to withstand public scrutiny.

The following policy rescinds and supersedes the October 27, 2011 memorandum from the Deputy Secretary “Eliminating Excess Conference Spending and Promoting Efficiency in Government,” and is in addition to and is intended to complement the requirements and procedures set forth in the following policies, or any updates thereto:

· HHS Travel Manual, May 2008

· Memorandum from the General Counsel “Agency Gift Acceptance Authorities and the Co-Sponsorship of Events with Outside Non-Federal Entities,” August 8, 2002

Contractor(s) shall make all appropriate efforts to conduct business, including meetings, and host or sponsor conferences in space controlled by the Federal Government, wherever practicable and cost effective.

It is the Department’s policy that contractor(s) shall not use appropriated funds (whether from an annual appropriation, multi-year appropriation, appropriated user fee, mandatory appropriation, gift funds, or reimbursements from such appropriations, etc.) to purchase food (whether for conferences or meetings; for meals, light refreshments, or beverages; or for Federal or non-Federal participants) unless contractor(s) document that the provision of food is a necessary expense and one of the established exceptions applies.

It is the Department’s policy that contractor(s) shall not use appropriated funds (whether from an annual appropriation, multi-year appropriation, appropriated user fee, mandatory appropriation, gift funds, or reimbursements from such appropriations, etc.) to purchase promotional items when they are not a necessary expense. Any such necessary expense justification must be in writing, explain why the purchase is a necessary expense that is critical to the mission and why the costs are considered reasonable, and be included in the associated administrative file, such as the purchase card request or contract file.

It is the Department’s policy that printing and publication of hard copy materials be consistent with HHS missions, objectives and existing policies; represent the efficient and effective use of taxpayer funds; and withstand public scrutiny, while not creating barriers for the public in obtaining our information. Information should now be presumed to be provided in an electronic form, whenever practicable, permitted by law, and consistent with applicable records and retention requirements. Contractor(s) should therefore limit the publication and printing of hard copy documents for internal and external use in relation to this contract. This policy is in addition to existing statutory and regulatory requirements for Printing and Publications.

The following statement must be included on requirements where conference materials, including promotional materials, agenda, and Internet sites are anticipated:

Funding for this conference was made possible in part by the Office of Extramural Research, National Institutes of Health, Department of Health and Human Services. Appropriated funds shall not be used to purchase meals, light refreshments, or beverages for conferences or meetings conducted under this requirement. Additionally, the general printing, copying, and scanning of routine documents by the contractor, are expected to use sustainable practices to meet their needs, where applicable, such as:

· double-sided printing;

· black and white printing vs. color;

· use of 'draft' quality rather than 'high' quality printing;

· use of sleep mode when printers and copies are not in use

· use of toner-efficient fonts;

· narrow margins on network printers; and

· limit use of desktop printers and shift to network printers unless an exception is granted

Sensitive Information Protection

The Government has determined that any information/data that the Contractor will be provided during the performance of the contract will be of a sensitive nature; therefore, the contractor will be required to sign a confidentiality agreement with the NIH and also with each participating company as described above in the Confidentiality of Information section.

Non-personal Services As stated in the Federal Register, Volume 57, No. 190, page 45096, dated September 30, 1992, Policy Letter on Inherently Governmental Functions, no personal services shall be performed under this contract. All work requirements shall flow only from the Project Officer to the Contractor's Project Manager. No Contractor employee will be directly supervised by the Government. All individual employee assignments, and daily work direction, shall be given by the applicable employee supervisor. If the Contractor believes any Government action or communication has been given that would create a personal services relationship between the Government and any Contractor employee, the Contractor shall promptly notify the Contracting Officer of this communication or action.

The Contractor shall not perform any inherently Governmental actions under this contract. No Contractor employee shall hold him or herself out to be a Government employee, agent, or representative. No Contractor employee shall state orally or in writing at any time that he or she is acting on behalf of the Government. In all communications with third parties in connection with this contract, Contractor employees shall identify themselves as Contractor employees and specify the name of the company for which they work. In all communications with other Government contractors in connection with this contract, the Contractor employee shall state that he/she has no authority to, in any way, change the contract and that if the other contractor believes this communication to be a direction to change their contract, they should notify the Contracting Officer for that contract and not carry out the direction until a clarification

The contractor shall insure that all of its employees working on this contract are informed of the substance of this article. Nothing in this article shall limit the Government’s rights in any way under the other provisions of the contract, including those related to the Government’s right to inspect and accept the services to be performed under this contract. The substance of this article shall be included in all subcontracts at any tier.

FAR Clauses Incorporated by Reference

FEDERAL ACQUISITION REGULATION (FAR) CLAUSES INCORPORATED BY REFERENCE

This Delivery Order incorporates the following additional Federal Acquisition Regulation (FAR) clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available. Also, the full text of a FAR clause may be accessed electronically at http://www.arnet.gov/far/.

FAR 37.1, Service Contracts -- General

FAR 39.106, Year 2000 Compliance

FAR 39.2, Electronic and Information Technology

FAR 52.204-9, Personal Identity Verification of Contractor Personnel

FAR 52.217-5, Evaluation of Options

FAR 52.222-26, Equal Opportunity

FAR 52.227-14, Rights in Data-General

FAR 52.232-1 Payments

FAR 52.232-33, Payment by Electronic Funds Transfer – Central Contractor Registration

FAR 52.232-58, Prompt Payment

FAR 52.233-1 Disputes

FAR 52.239-1, Privacy and Security Safeguards

FAR 52.245-1, Government Property

FAR 52.246-4, Inspection of Services – Fixed Price

b. FAR 52.252-2, Clauses Incorporated by Reference (Feb 1998). This contract incorporates one or more clauses by reference, with the same force and effect as if they were given in full text. Upon request, the Contracting Officer will make their full text available.

c. Inspection/Acceptance. The Contractor shall tender for acceptance only those items that conform to the requirements of this contract. The Government reserves the right to inspect or test any supplies or services that have been tendered for acceptance. The Government may require repair or replacement of nonconforming supplies or re-performance of nonconforming services at no increase in contract price. The Government must exercise its post-acceptance rights --

d. (1) Within a reasonable period of time after the defect was discovered or should have been discovered; and

e. (2) Before any substantial change occurs in the condition of the item, unless the change is due to the defect in the item.

f. Excusable delays. The Contractor shall be liable for default unless nonperformance is caused by an occurrence beyond the reasonable control of the Contractor and without its fault or negligence, such as acts of God or the public enemy, acts of the Government in either its sovereign or contractual capacity, fires, floods, epidemics, quarantine restrictions, strikes, unusually severe weather, and delays of common carriers. The Contractor shall notify the Contracting Officer in writing as soon as it is reasonably possible after the commencement of any excusable delay, setting forth the full particulars in connection therewith, shall remedy such occurrence with all reasonable dispatch, and shall promptly give written notice to the Contracting Officer of the cessation of such occurrence.

g. Termination for the Government’s convenience. The Government reserves the right to terminate this contract, or any part hereof, for its sole convenience. In the event of such termination, the Contractor shall immediately stop all work hereunder and shall immediately cause any and all of its suppliers and subcontractors to cease work. Subject to the terms of this contract, the Contractor shall be paid a percentage of the contract price reflecting the percentage of the work performed prior to the notice of termination, plus reasonable charges that the Contractor can demonstrate to the satisfaction of the Government, using its standard record keeping system, have resulted from the termination. The Contractor shall not be required to comply with the cost accounting standards or contract cost principles for this purpose. This paragraph does not give the Government any right to audit the Contractor’s records. The Contractor shall not be paid for any work performed or costs incurred that reasonably could have been avoided.

h. Termination for cause. The Government may terminate this contract, or any part hereof, for cause in the event of any default by the Contractor, or if the Contractor fails to comply with any contract terms and conditions, or fails to provide the Government, upon request, with adequate assurances of future performance. In the event of termination for cause, the Government shall not be liable to the Contractor for any amount for supplies or services not accepted, and the Contractor shall be liable to the Government for any and all rights and remedies provided by law. If it is determined that the Government improperly terminated this contract for default, such termination shall be deemed a termination for convenience.

i. Warranty. The Contractor warrants and implies that the items delivered hereunder are merchantable and fit for use for the particular purpose described in this contract.

DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) ACQUISITION REGULATION (HHSAR) CLAUSE INCORPORATED BY REFERENCE

The following HHSAR clause is hereby incorporated into this Delivery Order by reference with the same force and effect as if it were given in full text. Upon request, the Government will make its full text available. Also, the full text of a HHSAR clause may be accessed electronically at this address: http://www.os.hhs.gov/oamp/dap/hhsar.html.

HHSAR 352.270-5, Key Personnel

HHSAR 339.201, Acquisition of Information Technology

j. (iii) 52.222-35, Equal Opportunity for Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212) (Applies to contracts of $100,000 or more).

k. (iv) 52.222-36, Affirmative Action for Workers with Disabilities (Jun 1998) (29 U.S.C. 793) (Applies to contracts over $10,000, unless the work is to be performed outside the United States by employees recruited outside the United States.) (For purposes of this clause, United States includes the 50 States, the District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, and Wake Island.)

l. (v) 52.222-37, Employment Reports on Special Disabled Veterans, Veterans of the Vietnam Era, and Other Eligible Veterans (Sep 2006) (38 U.S.C. 4212) (Applies to contracts of $100,000 or more).

m. (vi) 52.222-41, Service Contract Act of 1965, As Amended (Jul 2005) (41 U.S.C. 351, et seq.) (Applies to service contracts over $2,500 that are subject to the Service Contract Act and will be performed in the United States, District of Columbia, Puerto Rico, the Northern Mariana Islands, American Samoa, Guam, the U.S. Virgin Islands, Johnston Island, Wade Island, or the outer continental shelf lands).

OTHER CLAUSES INCORPORATED BY REFERENCE

Privacy Act of 1974

Confidential Treatment of Sensitive Information

Section 508 Compliance

Rights in Data Pursuant to Federal Acquisition Regulations, Part 27, Subpart 27.4 – Rights in Data and Copyrights, this contract is subject to FAR 52.227-14 Rights in Data –General.

All property rights, including publication rights, in the information and materials first produced by the Contractor in connection with this award shall vest in the Office of Extramural Programs (OEP). Information and materials shall include, but are not limited to, progress reports, work plans, source code, draft, and final documents. The Contractor shall not embed its company name or logos or claim copyright for any deliverable submitted under this statement of work.

Upon completion of the tasks described in this statement of work, the Contractor shall submit to the COTR and or the designated Federal Project Manager(s)/Lead(s) all working papers, including handwritten notes and computerized information generated by these activities.

In accordance with FAR 52.227-14(b), the Contractor shall guarantee strict confidentiality of the information/data that is provided by the Government during the performance of the contract. The Government has determined that some of the information/data that the Contractor will be provided during the performance of the contract is of a sensitive nature and cannot be disclosed in any manner.

The Contractor, in whole or in part, can only make disclosure of the sensitive information/data, after the Contractor receives prior written approval from the CO. Whenever the Contractor is uncertain with regard to the proper handling of information/data under the contract, the Contractor shall obtain a written determination from the CO.

Privacy Act of 1974 This SOW may require the Contractor to do one or more of the following: design, develop, or operate a system of records on individuals to accomplish an agency function in accordance with the Privacy Act of 1974, Public Law 93-579, December 31, 1974 (5 USC 552a) and applicable agency regulations. Violation of the Act may involve the imposition of criminal penalties. The Privacy Act System of Records applicable to this project is Number 09-90-0024. Complete text of Privacy Act can be found at http://www.gpoaccess.gov/privacyact/2003.html.

Section 508 Compliance

This language is applicable to Statements of Work (SOW) generated by the Department of Health and Human Services (HHS) that require a contractor or consultant to (1) produce content in any format that could be placed on a Department-owned or Department-funded Web site; or (2) write, create or produce any communications materials intended for public or internal use; to include reports, documents, charts, posters, presentations (such as Microsoft PowerPoint) or video material that could be placed on a Department-owned or Department-funded Web site.

Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d) requires Federal agencies to purchase electronic and information technologies (EIT) that meet specific accessibility standards. This law helps to ensure that federal employees with disabilities have access to, and use of, the information and data they need to do their jobs. Furthermore, this law ensures that members of the public with disabilities have the ability to access government information and services.

There are three regulations addressing the requirements detailed in Section 508. The Section 508 technical and functional standards are codified at 36 CFR Part 1194 and may be accessed through the Access Board’s Web site at http://www.access-board.gov. The second regulation issued to implement Section 508 is the Federal Acquisition Regulation (FAR). FAR Part 39.2 requires that agency acquisitions of Electronic and Information Technology (EIT) comply with the Access Board’s standards. The entire FAR is found at Chapter 1 of the Code of Federal Register (CFR) Title 48, located at http://www.acquisition.gov. The FAR rule implementing Section 508 can be found at http://www.section508.gov. The third applicable regulation is the HHS Acquisition Regulation (HHSAR).

Regardless of format, all Web content or communications materials produced for publication on or delivery via HHS Web sites - including text, audio or video - must conform to applicable Section 508 standards to allow federal employees and members of the public with disabilities to access information that is comparable to information provided to persons without disabilities. All contractors (including subcontractors1) or consultants responsible for preparing or posting content intended for use on an HHS-funded or HHS-managed Web site must comply with applicable Section 508 accessibility standards, and where applicable, those set forth in the referenced policy or standards documents below. Remediation of any materials that do not comply with the applicable provisions of 36 CFR Part 1194 as set forth in the SOW or PWS, shall be the responsibility of the contractor or consultant retained to produce the Web-suitable content or communications material.

The following Section 508 provisions apply to the content or communications material identified in this SOW or PWS:

[Project Officer must list the applicable provisions of the Access Board Final Rule (36 CFR Part 1194) – e.g., “36 CFR 1194.21(a)-(j)”] 1 Prime contractors may enter into subcontracts in the performance of a Federal contract, but the prime remains obligated to deliver what is called for under the contract.

Place of Performance The services required under the award shall be completed at the following location:

Mainland United States. (Specific address may be determined at the time of award.)

Evaluation Criteria (in order of importance)

1. Soundness and Merit of Technical Approach (25 points) The contractor shall demonstrate and will be evaluated on the soundness of the technical approach and ability to complete the required tasks by illustrating (through example), the planned approach, management, scheduling, and assignment of tasks under the SOW.

2. Technical Qualifications (25 points) The contractor shall submit adequate qualifications (e.g. resumes for each key person will be evaluated in this category) of the contractor and its team of advisors to provide business guidance to both early stage and seasoned small companies with diverse technologies ranging from those in the clinic (e.g., drugs, therapeutics, medical devices), to basic research tools, to healthcare and IT products.

3. Technical Knowledge (25 points) Contractor shall provide demonstrated evidence of knowledge of the biotechnology partnering, licensing and investment community and contractor’s ability to attract their interest in NIH SBIR- and STTR- developed products as specifically outlined in the tasks within the SOW.

4. Technical Capability (15 points) Contractor shall demonstrate their ability to analyze statistical commercialization data (e.g.resumes of key personnel with relevant expertise, corporate resources, and other capabilities and tools).

5. Past Performance (10 points) Contractor shall provide proven capability to carry out the requested work effectively and in a timely fashion based on references provided by the contractor. The government will also use other relevant past performance information (e.g. overall quality of past performance on services related to those required in this SOW) obtained from other sources known to NIH.

The Government will award a contract to the contractor that represents the best value to the Government based on the factors shown above. The Government reserves the right to award to other than the lowest priced offer.