Sol_Doc_75F40125R00037_Attachment 6 - Trial Subscription Agreement.docx

Access to Outpatient Longitudinal Data IDIQ 75F40125R00037 Attachment 6

ATTACHMENT 6: TRIAL SUBSCRIPTION AGREEMENT

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.

Background: [ * ] has developed an internet-accessible or network-based outpatient drug utilization 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.

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.

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.

Proprietary Information:

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

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

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

1. 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;

1. 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;

1. 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

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

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.

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: __________________________