Orange Book Companion®
Terms and Conditions
Payments are non-refundable unless it becomes impossible for FDLI to access, extract, and reproduce data and information from FDA's electronic Orange Book files. In such case, FDLI will inform the Subscriber of this situation and a pro-rated refund for the number of months remaining in the subscription may be requested.
Online subscriptions will start the day after FDLI sends the user ID and password to the Subscriber Contact Person*. Every employee and contract worker in Subscriber's organization who has authorization from the Subscriber to the Subscriber's Intranet system is eligible to use the account. Any such eligible person may access the account from any web-connected computer, whether from home using his/her own Internet service or while traveling.
The Online subscription account information (user ID and password) may not be shared outside the Subscriber's organization. Employees of affiliated organizations that share a common Intranet with the Subscriber may also use the account. If an affiliated organization does not share a common Intranet with the Subscriber, that affiliated organization must purchase a separate subscription.
The log file for the Online system counts the number of times that a user ID is used to access the system. No further usage information tied specifically to a user ID is available to FDLI. If a change in usage statistics suggests that the account information has become available to ineligible entities, FDLI will notify the Subscriber Contact Person and replace the password with a new one. If FDLI learns that a Subscriber has made or permitted account information to be available to, shared with, distributed to, or duplicated for ineligible parties, FDLI may cancel the subscription without penalty to itself and without providing a refund to the Subscriber.
A CD-ROM subscription will start with the current FDA Orange Book supplement. CD-ROMs will be mailed First Class to the Subscriber Contact Person each month. A "base" subscription entitles the Subscriber to copy the contents of the CD-ROM to a single Intranet server. The "base" subscription and any "additional" subscriptions entitle each recipient of a CD-ROM to copy the contents of that CD-ROM to the hard drive of a single computer. Neither the CD-ROM nor its contents may be duplicated or distributed.
The Subscriber is totally responsible for making the CD-ROM files available over the Subscriber's Intranet or copying the files to a computer hard drive. Each CD-ROM contains a Home Page (index.htm) that has links to the data files.
Any act on the part of the Subscriber, its agents, or employees capable of causing the Online or CD-ROM files to be available to the public is strictly prohibited, and will result in the cancellation of the subscription without refund. The arrangement and presentation of data in the data files are protected by copyright. FDLI reserves the right to take any action to which FDLI is entitled by law, in addition to cancellation of the subscription, for the unauthorized distribution of any of the files.
Warranty Disclaimer
By using the Orange Book Companion files that are provided under a subscription, the Subscriber expressly acknowledges and agrees that the use of the files is at the Subscriber's own risk. The files are provided "as is." There is no warranty, expressed or implied, including any warranty of merchantability or fitness for a particular purpose. There is no warranty that the files will be error free.
Limitation of Liability
Under no circumstances, including negligence, shall FDLI be liable for any incidental, special, or consequential damages that result from the use or inability to use the files, even if FDLI has been advised of the possibility of such damages. In no event shall FDLI's total liability to the Subscriber or to any third party exceed the amount paid for the annual subscription for the year in question.
* "Subscriber Contact Person" is the specific individual who placed the subscription order.