Appendix_A-H.pdf

APPENDIX A

Glossary

Ad-hoc services – additional analytical and programming support, to enable FDA personnel to obtain ad hoc analyses or custom queries not available through the online data tools.

Aggregated data – any data that has been re-formatted or derived from the original data report or data set, e.g., raw data. Aggregated data are typically presented in tables, charts, and text.

Commercially available – The data resource, or access to it, has available for sale or has been sold to the general public as of June 1, 2015 (Note: The FDA does not intend to use this solicitation to initiate or complete development of a resource.)

Currently existing – The data chosen for this award must be a commercially available product at the time of the proposal. The FDA does not intend to use this solicitation to initiate or complete development of a resource.

Data dictionary – A document that describes the information available in the data resource. This information shall minimally include field or variable name, description, definition (including business rules for computed fields and missing data), and allowed values. All fields or variables in the data resource should be included in this document.

Desktop – Authorized FDA personnel should be able to access the data from their own computers (i.e., no special or customized hardware should be required for access)

Direct – Authorized FDA personnel should be able to access raw or sample numbers from the data source from their desktop (i.e., no intervention on the contractor's part should be necessary. In addition, output that consists of formatted reports only will not be acceptable).

Full disclosure of data collection – The FDA shall receive detailed information on how the sample is selected, how data are obtained and cleaned/edited for analysis, how the data was built, how variables are defined, and the relationship between variables within the data structure.

Firewall-to-firewall virtual private network (VPN) – Secure TCP/IP connection between two firewalls that simulates a local area network. Encryption/decryption and authentication are mandatory for the VPN solution.

Immediate – Authorized FDA personnel should be able to access the data whenever needed without intervention on the contractor’s part.

Multi-user environment – Two or more authorized FDA users should be able to access the data at the same time from different locations.

Projection or other appropriate methodologies – A projection methodology is an algorithm that can be used to estimate drug utilization for the U.S. population in a valid, reliable, and robust manner using the sample captured in the data. Appropriate methodologies may include, but are not limited to, gathering drug utilization data on the universe of prescriptions/patients (e.g., a “census” method), which may reduce or eliminate the need for projection. Should a ”census” method be chosen, the Contractor shall provide mutually acceptable evidence that the data are adequately representative of outpatient drug utilization in the U.S.

Raw data – data in its original format, not aggregated data, as supplied by the data vendor.

Real-time – Real-time access refers to the responsiveness of the database to input, specifically where an event, such as inputting query parameters or submitting a query, produces a rapid response within a matter of minutes, if not seconds. FDA expects the contractor to provide information on the typical expected response time to both query parameter input and query submissions.

Reliable – The projection method used must yield the same or similar results in the same or similar situations (e.g., must be reproducible and repeatable).

Robust – in cases where the assumptions underlying the projection or other appropriate methodology are not all met, the results obtained should be the same or similar as in situations where all assumptions and conditions are fully met.

Secure – At no time will passwords, login, or data be open to inspection or intrusion by unauthorized parties.

Secure Internet Access – Browser based, encrypted point-to-point access using hypertext transmission protocol, secure (HTTPS) or Secure Socket Layer (SSL).

Unlimited – authorized FDA personnel shall have the ability to use any data element in the database in any combination or query that is necessary to address a specific issue.

Valid – an assessment of how well the projected values reflect what is actually happening in the entire population of interest.

APPENDIX B

Census Regions

Northeast: Connecticut, Maine, Massachusetts, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Vermont

Midwest: Illinois, Indiana, Iowa, Kansas, Michigan, Minnesota, Missouri, Nebraska, North Dakota, Ohio, South Dakota, Wisconsin

South: Alabama, Arkansas, Delaware, District of Columbia, Florida, Georgia, Kentucky, Louisiana, Maryland, Mississippi, North Carolina, Oklahoma, South Carolina, Tennessee, Texas, Virginia, West Virginia

West: Alaska, Arizona, California, Colorado, Hawaii, Idaho, Montana, Nevada, New Mexico, Oregon, Utah, Washington, Wyoming

APPENDIX C

Section 508 Standards

Section 508 of the Rehabilitation Act Amendments of 1998 (29 U.S.C. § 794 (d) was enacted in the Workforce Investment Act of 1998. Section 508 requires that when Federal agencies develop, procure, maintain, or use electronic and information technology, Federal employees with disabilities have access to and use of information and data that is comparable to the access and use by Federal employees who are not individuals with disabilities. The Act required the Architectural and Transportation Barriers Compliance Board (Access Board) to create federal standards for electronic and information technology (EIT) products (goods and services) to make them more accessible by individuals with disabilities.

Each Offeror will be evaluated on their conformance to the Section 508 Standards identified below as being applicable for this requirement. The conformance to these standards will be evaluated as follows:

1. Conformance at proposal submission

2. Conformance by scheduled delivery date, after insignificant or no contractor development

3. Conformance by scheduled delivery date, after significant contractor development

No allowance is given here for partial performance as gradations are difficult to verify and add complexity.

Using the following web site, Offerors can access resources for understanding and implementing the requirements of Section 508 http://www.section508.gov (See Appendices C & D)

The following applications standards have been identified as being applicable for this service:

§ 1194.21 Software applications and operating systems.

(a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually.

(b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer.

(c) A well-defined on-screen indication of the current focus shall be provided that moves among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that assistive technology can track focus and focus changes.

(d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to assistive technology. When an image represents a program element, the information conveyed by the image must also be available in text.

(e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application's performance.

(f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes.

(g) Applications shall not override user selected contrast and color selections and other individual display attributes.

(h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user.

(i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element.

(j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided.

(k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2 Hz and lower than 55 Hz.

(l) When electronic forms are used, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

§ 1194.22 Web-based intranet and internet information and applications.

a) A text equivalent for every non-text element shall be provided (e.g., via "alt", "longdesc", or in element content).

(b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation.

(c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup.

(d) Documents shall be organized so they are readable without requiring an associated style sheet.

(e) Redundant text links shall be provided for each active region of a server-side image map.

(f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape.

(g) Row and column headers shall be identified for data tables.

(h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers.

(i) Frames shall be titled with text that facilitates frame identification and navigation.

(j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz.

(k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes.

(l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by assistive technology.

(m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with §1194.21(a) through (l).

(n) When electronic forms are designed to be completed on-line, the form shall allow people using assistive technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

(o) A method shall be provided that permits users to skip repetitive navigation links.

(p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required.

Note to §1194.22:

1. The Board interprets paragraphs (a) through (k) of this section as consistent with the following priority 1 Checkpoints of the Web Content Accessibility Guidelines 1.0 (WCAG 1.0) (May 5, 1999) published by the Web Accessibility Initiative of the World Wide Web Consortium:

Section 1194.22 Paragraph WCAG 1.0 Checkpoint

(a) 1.1

(b) 1.4

(c) 2.1

(d) 6.1

(e) 1.2

(f) 9.1

(g) 5.1

(h) 5.2

(i) 12.1

(j) 7.1

(k) 11.4

2. Paragraphs (l), (m), (n), (o), and (p) of this section are different from WCAG 1.0. Web pages that conform to WCAG 1.0, level A (i.e., all priority 1 checkpoints) must also meet paragraphs (l), (m), (n), (o), and (p) of this section to comply with this section. WCAG 1.0 is available at http://www.w3.org/TR/1999/WAI-WEBCONTENT-19990505.

§ 1194.31 Functional performance criteria.

(a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for assistive technology used by people who are blind or visually impaired shall be provided.

(b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for assistive technology used by people who are visually impaired shall be provided.

(c) At least one mode of operation and information retrieval that does not require user hearing shall be provided, or support for assistive technology used by people who are deaf or hard of hearing shall be provided.

(d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided.

(e) At least one mode of operation and information retrieval that does not require user speech shall be provided, or support for assistive technology used by people with disabilities shall be provided.

(f) At least one mode of operation and information retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided.

http://www.w3.org/TR/1999/WAI-WEBCONTENT-19990505

§ 1194.41 Information, documentation, and support.

(a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge.

(b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge.

(c) Support services for products shall accommodate the communication needs of end-users with disabilities.

The following applications standards have been determined to not be applicable for this service:

§ 1194.23 Telecommunications products.

§ 1194.24 Video and multimedia products.

§ 1194.25 Self-contained, closed products.

§ 1194.26 Desktop and portable computers.

APPENDIX D

Voluntary Product Accessibility Template™

Version 1.2

The purpose of the Voluntary Product Accessibility Template, or VPAT™, is to assist Federal contracting officials and other buyers in making preliminary assessments regarding the availability of commercial "Electronic and Information Technology" products and services with features that support accessibility. It is assumed and recommended that offerers will provide additional contact information to facilitate more detailed inquiries.

The first table of the Template provides a summary view of the section 508 Standards. The subsequent tables provide more detailed views of each subsection. There are three columns in each table. Column one of the Summary Table describes the subsections of subparts B and C of the Standards. The second column describes the supporting features of the product or refers you to the corresponding detailed table, "e.g., equivalent facilitation." The third column contains any additional remarks and explanations regarding the product. In the subsequent tables, the first column contains the lettered paragraphs of the subsections. The second column describes the supporting features of the product with regard to that paragraph. The third column contains any additional remarks and explanations regarding the product.

Date:

Name of Product:

Company contact for more Information:

Summary Table Voluntary Product Accessibility Template

Criteria Supporting Features Remarks and explanations

Section 1194.21 Software Applications and Operating Systems

Section 1194.22 Web-based Internet Information and Applications

Section 1194.23 Telecommunications Products

Section 1194.24 Video and Multi-media Products http://www.access-star.org/ITI-VPAT-v1.2.html#softwaredetails#softwaredetails http://www.access-star.org/ITI-VPAT-v1.2.html#softwaredetails#softwaredetails http://www.access-star.org/ITI-VPAT-v1.2.html#webdetails#webdetails http://www.access-star.org/ITI-VPAT-v1.2.html#webdetails#webdetails http://www.access-star.org/ITI-VPAT-v1.2.html#telecommunicationsdetails#telecommunicationsdetails http://www.access-star.org/ITI-VPAT-v1.2.html#videodetails#videodetails http://www.access-star.org/ITI-VPAT-v1.2.html#videodetails#videodetails

Section 1194.25 Self-Contained, Closed Products

Section 1194.26 Desktop and Portable Computers

Section 1194.31 Functional Performance Criteria

Section 1194.41 Information, Documentation and Support

Section 1194.21 Software Applications and Operating Systems – Detail

Criteria Supporting Features Remarks and explanations

(a) When software is designed to run on a system that has a keyboard, product functions shall be executable from a keyboard where the function itself or the result of performing a function can be discerned textually.

(b) Applications shall not disrupt or disable activated features of other products that are identified as accessibility features, where those features are developed and documented according to industry standards. Applications also shall not disrupt or disable activated features of any operating system that are identified as accessibility features where the application programming interface for those accessibility features has been documented by the manufacturer of the operating system and is available to the product developer.

(c) A well-defined on-screen indication of the current focus shall be provided that moves http://www.access-star.org/ITI-VPAT-v1.2.html#selfcontaineddetails#selfcontaineddetails http://www.access-star.org/ITI-VPAT-v1.2.html#selfcontaineddetails#selfcontaineddetails http://www.access-star.org/ITI-VPAT-v1.2.html#desktopsdetails#desktopsdetails http://www.access-star.org/ITI-VPAT-v1.2.html#desktopsdetails#desktopsdetails http://www.access-star.org/ITI-VPAT-v1.2.html#functionaldetails#functionaldetails http://www.access-star.org/ITI-VPAT-v1.2.html#functionaldetails#functionaldetails http://www.access-star.org/ITI-VPAT-v1.2.html#informationdetails#informationdetails http://www.access-star.org/ITI-VPAT-v1.2.html#informationdetails#informationdetails among interactive interface elements as the input focus changes. The focus shall be programmatically exposed so that Assistive Technology can track focus and focus changes.

(d) Sufficient information about a user interface element including the identity, operation and state of the element shall be available to Assistive Technology. When an image represents a program element, the information conveyed by the image must also be available in text.

(e) When bitmap images are used to identify controls, status indicators, or other programmatic elements, the meaning assigned to those images shall be consistent throughout an application's performance.

(f) Textual information shall be provided through operating system functions for displaying text. The minimum information that shall be made available is text content, text input caret location, and text attributes.

(g) Applications shall not override user selected contrast and color selections and other individual display attributes.

(h) When animation is displayed, the information shall be displayable in at least one non-animated presentation mode at the option of the user.

(i) Color coding shall not be used as the only means of conveying information, indicating an action, prompting a response, or distinguishing a visual element.

(j) When a product permits a user to adjust color and contrast settings, a variety of color selections capable of producing a range of contrast levels shall be provided.

(k) Software shall not use flashing or blinking text, objects, or other elements having a flash or blink frequency greater than 2 Hz and lower than 55 Hz.

(l) When electronic forms are used, the form shall allow people using Assistive Technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

Section 1194.22 Web-based Internet information and applications – Detail

Criteria Supporting Features Remarks and explanations

(a) A text equivalent for every non-text element shall be provided (e.g., via "alt", "longdesc", or in element content).

(b) Equivalent alternatives for any multimedia presentation shall be synchronized with the presentation.

(c) Web pages shall be designed so that all information conveyed with color is also available without color, for example from context or markup.

(d) Documents shall be organized so they are readable without requiring an associated style sheet.

(e) Redundant text links shall be provided for each active region of a server-side image map.

(f) Client-side image maps shall be provided instead of server-side image maps except where the regions cannot be defined with an available geometric shape.

(g) Row and column headers shall be identified for data tables.

(h) Markup shall be used to associate data cells and header cells for data tables that have two or more logical levels of row or column headers.

(i) Frames shall be titled with text that facilitates frame identification and navigation

(j) Pages shall be designed to avoid causing the screen to flicker with a frequency greater than 2 Hz and lower than 55 Hz.

(k) A text-only page, with equivalent information or functionality, shall be provided to make a web site comply with the provisions of this part, when compliance cannot be accomplished in any other way. The content of the text-only page shall be updated whenever the primary page changes.

(l) When pages utilize scripting languages to display content, or to create interface elements, the information provided by the script shall be identified with functional text that can be read by Assistive Technology.

(m) When a web page requires that an applet, plug-in or other application be present on the client system to interpret page content, the page must provide a link to a plug-in or applet that complies with §1194.21(a) through (l).

(n) When electronic forms are designed to be completed on-line, the form shall allow people using Assistive Technology to access the information, field elements, and functionality required for completion and submission of the form, including all directions and cues.

(o) A method shall be provided that permits users to skip repetitive navigation links.

(p) When a timed response is required, the user shall be alerted and given sufficient time to indicate more time is required.

Note to 1194.22: The Board interprets paragraphs (a) through (k) of this section as consistent with the following priority 1 Checkpoints of the Web Content Accessibility Guidelines 1.0 (WCAG 1.0) (May 5 1999) published by the Web Accessibility Initiative of the World Wide Web Consortium: Paragraph (a) - 1.1, (b) - 1.4, (c) - 2.1, (d) - 6.1, (e) - 1.2, (f) - 9.1, (g) - 5.1, (h) - 5.2, (i) - 12.1, (j) - 7.1, (k) - 11.4.

Section 1194.31 Functional Performance Criteria - Detail Voluntary Product Accessibility Template™

Criteria Supporting Features Remarks and explanations

(a) At least one mode of operation and information retrieval that does not require user vision shall be provided, or support for Assistive Technology used by people who are blind or visually impaired shall be provided.

(b) At least one mode of operation and information retrieval that does not require visual acuity greater than 20/70 shall be provided in audio and enlarged print output working together or independently, or support for Assistive Technology used by people who are visually impaired shall be provided.

(c) At least one mode of retrieval that does not require user hearing shall be provided, or support for Assistive Technology used by people who are deaf or hard of hearing shall be provided

(d) Where audio information is important for the use of a product, at least one mode of operation and information retrieval shall be provided in an enhanced auditory fashion, or support for assistive hearing devices shall be provided.

(e) At least one mode of retrieval that does not require user speech shall be provided, or support for Assistive Technology used by people with disabilities shall be provided.

(f) At least one mode of retrieval that does not require fine motor control or simultaneous actions and that is operable with limited reach and strength shall be provided.

Section 1194.41 Information, Documentation and Support – Detail

Criteria Supporting Features Remarks and explanations

(a) Product support documentation provided to end-users shall be made available in alternate formats upon request, at no additional charge

(b) End-users shall have access to a description of the accessibility and compatibility features of products in alternate formats or alternate methods upon request, at no additional charge.

(c) Support services for products shall accommodate the communication needs of end-users with disabilities.

APPENDIX E

DATA DISCLOSURE CLEARANCE PROCEDURES

PURPOSE:

As provided for at FAR 52.227-14 (Alt II), [Name of Contractor] (“Contractor”) has provided a Limited Rights Notice to FDA (Appendix F) identifying Limited Rights Data (see definition below). This Limited Rights Notice authorizes FDA to disclose these Limited Rights Data for public health, safety, and regulatory purposes, provided that the disclosures of these data are made subject to prohibition against their further disclosure.

In accordance with the Limited Rights Notice, the purpose of this document is to establish timely clearance procedures for the FDA and Contractor to follow when FDA seeks either (1) to make Aggregated Limited Rights Data (see definition below) publicly available , or (2) to disclose actual Limited Rights Data to specific third parties subject to prohibition against their further disclosure.

DEFINITIONS:

Aggregated Limited Rights Data -- Any collective or summary presentation of Limited Rights Data that does not disclose any raw data accessed by FDA from [Name of Contractor] (Contractor) [Database System].

De-identified Data – Data that have had patient, hospital, and physician information removed, e.g., names, addresses, social security numbers, and dates of birth, so that any user or audience cannot purposefully or inadvertently discover a patient’s identity.

Limited Rights Data – For purposes of these data disclosure clearance procedures, the definition of Limited Rights Data provided at FAR 52.227-14 is understood to include raw data, accessed by FDA personnel through the [Database Systems].

Public Release – Any communications, meetings, or interactions where FDA personnel make information publicly available, including by disclosing it: to any private, public, or governmental entity other than in accordance with paragraph 5 of these procedures; at any public event, such as the public portion of an advisory committee meeting or a public presentation or demonstration; through any publication in any media, such as scientific and technical articles; or in any agency record that FDA makes available on a non-confidential basis to anyone outside FDA, including in accordance with the Freedom of Information Act.

PROCEDURES:

These clearance procedures do not apply to disclosure of information, including of Limited Rights Data and/or Aggregated Limited Rights Data, made in response to an authorized request of Congress or any other government body of competent jurisdiction (see [section of primary agreement in which such disclosures are discussed] [Database System] (“Agreement”).

1. FDA and Contractor shall complete the Clearance Procedure Cover Sheet (Appendix F is a blank copy) upon execution of the Agreement. This form provides the names and contact information for individuals who shall serve as the primary contact (Contact) for each party. Each party must update the Cover Sheet any time its contact information or its Contact changes.

2. For each proposed disclosure, FDA shall submit a Clearance Request Form (Appendix F is a blank copy), a copy of the materials to be disclosed, and the final dataset used to prepare those materials, which shall reflect any calculations or transformations.

3. FDA shall identify Contractor as the data source when disclosing Aggregated Limited Rights Data or Limited Rights Data.

4. Within 24 hours of receipt for urgent clearance request and 48 hours for standard request by the Contractor's Contact of the Clearance Request Form, Contractor shall provide a clearance decision for the requested Public Release of Aggregated Limited Rights Data.

5. Within 72 hours of receipt by the Contractor's Contact of the Clearance Request Form, the Contractor shall provide a clearance decision for disclosure of Limited Rights Data to a third party in accordance with the following conditions:

a. The third party must be actively engaged in a project initiated by FDA;

b. Clearance to share the data with the third party shall be granted only for purposes of the FDA initiated project and shall not extend beyond the duration of the third party's active engagement in that project;

c. The third party must execute in a timely manner the required Contractor Third Party Access agreement and agree in writing to return any copies of the data provided to, or made by, that party when the third party is no longer actively engaged in such project or at such earlier time as FDA may request in writing;

and

d. The third party must agree in writing not to release the Limited Rights Data to any additional party.

6. If a third party that received Limited Rights Data in accordance with paragraph 5 seeks to disclose materials that include Aggregated Limited Rights Data, the third party must submit an electronic copy of those materials and of the source data files and/or final dataset relied upon to FDA for submission to the Contractor for clearance approval.

7. Clearance to use Limited Rights Data and/or Aggregated Limited Rights Data does not grant any third party rights to use the (Name of Contractor) (Contractor) [Database Systems] software tools.

TERM:

This policy shall be in effect for the calendar year for the length of the contract and thereafter until either party notifies the other of its termination or Contractor provides to the FDA a different policy.

APPENDIX F

DATA DISCLOSURE CLEARANCE FORMS

APPENDIX G

Exchanging Certificates with the External Individual and FDA Secure Electronic Mail System

1. To obtain a commercial grade U.S. Domestic 1024-bit key certificate, the Contractor will need to send a signed message to the address securemail@fda.hh.gov with a subject line of External Secure Electronic Mail. Once the e-mail is received, an e-mail administrator will contact you with instructions on the next steps.

COR shall be responsible for follow up with the Contractor to assure that process is being adhered to in its entirety.

mailto:securemail@fda.hh.gov

APPENDIX H

TRIAL SUBSCRIPTION AGREEMENT

BETWEEN [ * ] AND THE FOOD AND DRUG ADMINISTRATION

This Trial Subscription Agreement ("Agreement") sets forth an agreement between [ * ] and the Center for Drug Evaluation and Research (CDER) of the Food and Drug Administration (FDA) for the purposes stated and under the terms and conditions as set forth herein.

1. Background: [ * ] has developed an internet-accessible or network-based national-level pharmaceutical sales database software program [ ** ]. As part of that effort, [ * ] is willing to extend to FDA a 30-day trial subscription of [ ** ] at no cost to FDA. At the conclusion of the trial subscription period, FDA may, at its discretion, choose to purchase a full subscription to [ ** ] or allow the subscription to lapse.

2. Ownership and Reservation of Rights: [ * ] reserves all rights not expressly granted herein.

Except as set forth in this Agreement, no express or implied license or right of any kind is granted to FDA, including, but not limited to, any right to know, use, produce, receive, reproduce, copy, market, sell, distribute, transfer, translate, modify, adapt, disassemble, decompile or reverse engineer [ * ] or the documentation or any portions thereof. FDA acknowledges and agrees that [ * ] owns all rights, title, and interest, including all copies and documentation thereof, regardless of the form in which the copies may exist, and that [ ** ] is not in the public domain.

3. Warranties: FDA agrees that [ ** ] is provided to FDA "as is.” All express or implied conditions, representations, and warranties, including any implied warranty or merchantability satisfactory quality or fitness for a particular purpose, are disclaimed.

4. Proprietary Information:

a. FDA acknowledges that [ ** ] is a commercially valuable, proprietary product of [ * ] and that it contains confidential information, inventions, processes, trade secrets and intellectual properties.

b. FDA agrees to hold data collected from [ ** ] in confidence and not to, directly or indirectly, copy, reproduce, distribute, transmit, duplicate, reveal, report, publish, disclose, cause to be disclosed, or transfer such data to any third party, or utilize such data for any purpose whatsoever other than as expressly contemplated by this Agreement. FDA shall require all of its employees, agents, independent contractors, and all others who have any access to [ ** ] to abide by the confidentiality and proprietary provisions of this Agreement. All obligations under this paragraph will expire upon [ ** ]

c. termination of the trial subscription unless FDA purchases a full subscription thereafter.

d. The foregoing obligations shall not apply if and to the extent that:

(i) FDA establishes that data which appears in [ ** ] were already known to FDA, without obligations to keep such information confidential, at initiation of the trial subscription period;

(ii) FDA establishes that data which appear in [ ** ] were received by FDA in good faith from a third party lawfully in possession thereof and having no obligation to keep such information confidential;

(iii) FDA establishes that data which appear in [ ** ] were publicly known at initiation of the trial subscription period or have become publicly known other than by a breach of this Agreement; or

(iv) FDA is ordered by an administrative agency or other governmental body of competent jurisdiction to disclose certain data that appear in [ ** ].

5. Limitation of Liability: To the fullest extent permitted by Federal law, in no event shall [ * ] be liable to the FDA for any loss, claim, damage, or liability, of whatsoever kind or nature that may arise from or in connection with this Agreement.

6. Term and Termination: This Agreement shall become effective upon its execution by both parties.

The term of this Agreement shall be thirty (30) days and shall continue in full force and effect until termination at the sole discretion of either party. At the conclusion of the trial subscription period, FDA shall immediately return to [ * ] any proprietary [ ** ] data or other confidential information, and all copies thereof, together with all documentation related to the [ ** ], unless FDA purchases a full subscription thereafter. In the event that a party hereto violates or is in default of any material provision of this Agreement or the FDA is legally required to disclose information to a third party, this Agreement will terminate immediately without notice. Either party may terminate the Agreement upon written notice to the other party.

IN WITNESS WHEREOF, the parties hereto have executed this Agreement by their duly authorized representative as of the effective date below.

Agreed to and accepted by: Agreed to and accepted by:

[ * ] Food and Drug Administration

Signature: ______________________ Signature: _______________________

Name: _________________________ Name: __________________________

Title: _________________________ Title: __________________________

Date: _________________________ Date: __________________________

* Name of Offeror

** Name of Database System