ETT_Statement_of_Work.pdf

Enterprise Technology Transfer System

Statement of Work (SOW)

1. INTRODUCTION/OVERVIEW

The National Institutes of Health (NIH) is seeking an invention, patent, licensing, and royalties management system in support of the Technology Transfer infrastructure within the NIH that is responsible for facilitating the transfer of knowledge, discoveries and technologies out to the rest of the world in a manner that gives benefit to the public. Through certain aspects of its Technology Transfer enterprise, the Federal Government strives, where appropriate, to transfer federally owned or originated technology to the private sector for commercial development, and to researchers for the continued advancement of science and the NIH’s mission. It is the Public Health Service's policy to coordinate its technology transfer activities among and within its Agencies consistent with its mission and responsibilities pursuant to the Federal Technology Transfer Act (FTTA) of 1986, as amended.

The Secretary of the Department of Health and Human Services (HHS) has designated the NIH as the lead agency for technology transfer and intellectual property (IP) matters for HHS; including the patenting and licensing of Government inventions and discoveries.

2. GENERAL INFORMATION

NIH’s mission is to seek fundamental knowledge about the nature and behavior of living systems and the application of that knowledge to improve human health, extend life, and reduce illness and disability. The NIH comprises twenty‐seven (27) separate Institutes and Centers that support both extramural and intramural programs. Pursuant to the Federal Technology Transfer Act (FTTA) of 1986, the NIH established a significant technology transfer program that includes the management, patenting, and licensing of inventions with commercial potential originating from research conducted at said intramural research programs. NIH’s current active patent prosecution docket is more than two thousand five hundred (2,500) cases. NIH is also currently managing one thousand seven hundred

(1700) active licenses associated with its intellectual property portfolio. NIH is seeking an enterprise system for the management of NIH‐owned intellectual property and related technology transfer activities.

3. SCOPE

Vendor shall furnish and customize software as specified in SOW.

4. REQUIREMENTS. VENDOR SHALL.

The contractor shall maintain highly responsive services while suggesting and implementing innovative process to promote Enterprise Technology Transfer System. The contractor must have extensive experience with customizing software.

Vendor shall provide a web‐based application interface, with the system to be hosted either on‐ premises at NIH or in a FedRAMP‐approved cloud solution. Vendor shall also provide an enterprise license that allows for 500 concurrent users and for 600 named users. NIH employs a complex workflow for technology transfer, with as many as 20 different user roles that require unique permissions to view, create, and/or edit different record types within the system.

The selected system must meet all Federal security guidelines, and offerors provide GPAT/VPAT documentation as part of their proposals.

Enterprise Technology Transfer System Functional Requirements

Support storing, searching, and retrieval of information about NIH Technology Transfer activities. The

Contractor shall:

Provide a mechanism to search archived files in designated locations on the NIH network and/or local computer

Allow users to attach files to all record types supported by the system

Allow users to store files and/or attach files to database records directly from MS Outlook, from mapped network drives, or from local computer drives

As part of searching database records, allow searching of attached files

Allow files attached to linked records to be opened from any record that links to those records

Allow creation of different identification number formats for different record types, as well as automatic generation of the next sequential identification number by the system when a new record is created

Automatically update information related to NIH personnel from NIH Employee Directory (NED)

Manage requests for collaboration from either internal or external parties

Create database records for individual requests for collaboration

Allow assignment of requests to specific system users for action

Record information about external parties who are interested in collaboration

Record notes about collaboration opportunities

Allow searching of previous requests for collaboration to find similar language or previous collaborations with the same external party

Support marketing activities to identify partners for agreements/licenses related to NIH‐owned technologies

Track individual marketing efforts related to specific technologies

Record information about external parties contacted during marketing efforts

Store information about methods of communication that are preferred by different types of potential partners

Record descriptive information about individual technologies regarding which NIH is seeking partners

Search database records related to marketing activities to identify external parties with interest in specific technologies, and to identify technologies that have been licensed by specific external parties

Provide templates and/or tools to generate marketing materials related to specific NIH‐owned technologies/ collaboration opportunities

Store information about external collaborators, NIH researchers, labs, and successful technologies for use in marketing activities

Establish Agreements

Provide templates and/or tools to generate commonly used types of draft agreements in MS

Word for further customization

Allow NIH to create “sets” of pre‐defined agreement terms for different types of agreement

Create records for individual agreements

Provide the ability to create activity checklists for each specific type of agreement

Assign agreement records to specific system users for action

Record information about potential agreement partners

Record analysis of agreement terms by NIH users in the agreement record

Support workflow to ensure review of agreement terms by appropriate NIH stakeholders

Record approval/rejection of agreement terms by authorized NIH stakeholders

Support collection/archiving of electronic signatures for final agreements

Manage Active Agreements

Record time‐bound and financial terms of individual agreements

Support recording of notes about financial and scientific progress and/or compliance with agreement terms

Support generation of alerts/reminders for dates specified in agreements

Support linking of agreement records to related technologies (inventions) – this requires the ability to search technology records from the agreement record

Provide workflow to support revision of agreements as part of monitoring activities

Provide workflow to support communications with responsible parties when noncompliance occurs

Manage Technologies

Create records for individual technologies (inventions)

Allow technologies to be categorized by means of multiple drop down lists within the technology record

Utilize a status field to track progress of technology development (e.g. experimental, preclinical, Phase I, etc.)

Link technology records to records for related inventors, agreements, patents, licenses, and partners – this requires the ability to search other record types from within the technology record interface to identify and link related records

Allow designated NIH users to record their analysis/assessment of the technology in the technology record

Support export of specified information from the technology record and selected attached documents for transmission to external parties

Establish Patents

Create records for individual patents

Link patent records to related technologies, licenses, inventors, and law firms

Record costs for actions related to issuance/maintenance of patents (fees, annuities, etc.)

Record specific tasks assigned to law firms and allow recording of cost estimates, authorization to perform work, and approval of completed work products

Record decisions to file/not file patents in specific jurisdictions

Record decisions to terminate issued patents

Establish Licenses

Create records for individual license applications

Link license application records to related patents and partners

Allow assignment of license applications to specific individuals for specific actions

Record analysis of license applications by NIH users in the license application records

Record NIH review and approval for exclusive licenses

Record analysis of license terms by NIH users in the license record

Support workflow to ensure review of license terms by designated NIH users

Record approval/rejection of agreement terms by authorized NIH users

Support collection/archiving of electronic signatures for final licenses

Administer Licenses

Create records for individual licenses

Link license records to related license applications, technologies, patents, and partners

Allow individual license terms to be recorded in the license record

Allow creation of license amendments that list just the terms that have been added/removed/modified in the original license; amendment records would be automatically linked to the original license record

Record payments owed based on regular royalties

Record payments owed based on sales reports

Allow multiple payments owed by a single partner for multiple licenses and/or products to be

“rolled up” into a single amount owed

Record payments received

Allow payments received to be split across multiple licenses and/or products

Allow entry of comments on payment applicability

Record formulas for calculating distribution of royalties (NOTE: Formulas must be based only on royalties actually received)

Record royalty funds disbursed to other parties

Manage License Terms

Generate alerts/reminders for dates and/or phased activities (activities that are contingent on the completion of a prior activity) specified in the license terms

Provide templates and/or tools for creation of “past due” notices to be sent to partners

Past‐due notices must consolidate all payments/deliveries/submissions owed by the licensee into a single message

Provide interface with Microsoft Outlook to support auto‐generation of emails for past due notices

Record receipt of progress/financial reports

Allow searches for missing progress/financial reports

Provide a means to flag licenses as “out of compliance” and allow searching for out‐of‐ compliance licenses and/or licensees (NOTE: NIH will determine the criteria for licenses being out of compliance – this requirement is only for a means to flag licenses that meet the established criteria)

Provide workflow to modify the terms of executed licenses, and record review and approval of the amendments by relevant stakeholders

Provide a means to record any waivers granted, informal accommodations made, or penalties imposed

Provide workflow for termination of out‐of‐compliance licenses

Allow creation of infringement action records

Provide workflow for review and approval of recommended courses of action for infringements

Support automated generation of emails related to different statuses of infringement actions

Allow assignment of infringement actions to specific individuals to complete specific tasks

Provide a means to record disposition of infringement actions

5. PERIOD OF PERFORMANCE.

The period of performance shall be for one (1) 12‐month base year and four (4) 12‐month option years.

6. INSPECTION AND ACCEPTANCE REQUIREMENTS.

All work will be inspected and approved by Government approving official at the completion of the job.

In addition, All work shall be completed in accordance with industry standards.