This site is intended for US healthcare professionals only.

Terms of Use

For the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement

Important Safety Information and Indications

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

Terms of Use

Updated as of December 2015

The information provided on Otonomy, Inc.’s (“Otonomy”, “we” or “us”) website for its product OTIPRIO® (ciprofloxacin otic suspension) (“OTIPRIO” or the “Product”) located at http://www.OTIPRIO.com (“site”) is for general informational and educational purposes about OTIPRIO only. The following Terms of Use apply to your use of this site and any of the content, materials or services provided in or through this site. Please read these Terms of Use before accessing or using this site. By accessing or using this site, you acknowledge that you have read, understood and agreed to be bound by the Terms of Use set forth below, just as if you had signed them. If you are not willing to be bound by these Terms of Use, you may not access or use this site.

Use of Site

Material from this site may be accessed and used solely for personal, non-commercial use, and users assume any and all responsibility for such use. Neither this site nor any portion of this site may be copied, reproduced, distributed, displayed or otherwise used or exploited for any commercial purpose without Otonomy’s written authorization. All copyright and other proprietary notices contained in materials must be preserved and retained.

You hereby agree to comply with all laws and regulations applicable to use of this site. You may not use this site to cause injury or damage to, or to harass or defame, any other business or individual, or for any other criminal or unlawful purpose, is prohibited.

The information on this site is intended for users located in the United States, should not be construed as a solicitation or promotion for any product or service, or for the use of any product or service in a way outside of the United States or that is prohibited by the laws and regulations of the United States. Users of this site assume all risk arising from use of this site.

Medical Information

MEDICAL OR OTHER INFORMATION PROVIDED ON THIS SITE IS FOR INFORMATIONAL PURPOSES ONLY AND IS NOT INTENDED AS A SUBSTITUTE FOR PROFESSIONAL MEDICAL ADVICE, DIAGNOSIS OR TREATMENT. IN PARTICULAR, YOU SHOULD NOT RELY UPON THE CONTENT CONTAINED HEREIN FOR DIAGNOSING A HEALTH PROBLEM OR DISEASE. DUE TO THE RAPID NATURE OF CHANGE IN MEDICAL SCIENCE, THE INFORMATION PROVIDED ON THIS SITE MAY NOT BE CURRENT. ALWAYS SEEK THE ADVICE OF YOUR PHYSICIAN OR OTHER QUALIFIED HEALTH PROVIDER WITH ANY QUESTIONS YOU MAY HAVE REGARDING ANY MEDICAL CONDITION YOU OR YOUR FAMILY MAY HAVE. NEVER DISREGARD PROFESSIONAL MEDICAL ADVICE OR DELAY IN SEEKING IT BECAUSE OF SOMETHING YOU HAVE READ ON THIS SITE.

Forward-Looking Information

This site contains forward-looking information about Otonomy’s business, operations and financial condition. Words such as “anticipates,” “believes,” “estimates,” “expects,” “intends,” “plans,” “seeks” and similar expressions that may be used on this site are intended to identify forward-looking statements that are subject to various known and unknown risks and uncertainties beyond Otonomy’s reasonable control. Such risks and uncertainties include, but are not limited to, those arising from research and development, clinical trials, regulatory approvals, third-party reimbursement, reliance on third-party manufacturers and suppliers, commercialization, competition, patents, product liability and adequate financing. Actual results may differ materially from the forward-looking information provided, and such forward-looking information is only current as of the time it was originally included in this site.

The information on this site is not intended and should not be construed as an offer to sell securities.

Proprietary Rights

We have invested a significant amount of time, effort, and resources in the creation of this site, which is protected by U.S. and international copyright and intellectual property laws. You understand and agree that Otonomy and/or its licensors retain all right, title, and interest in this site (including all copyrights, patents, service marks, trademarks and other intellectual property rights) and to all content, including without limitation, any and all medical and product information, text, data, graphics, images, sound, products, programs and other information provided on or to this site, whether by Otonomy or users and whether in print, machine-readable, visual or audible form (altogether, “Otonomy Content”). You may access, download, display, print and retain Otonomy Content from this site solely for your own personal, non-commercial use. The Otonomy Content may not be distributed, downloaded, uploaded, modified, reused, reproduced, reposted, retransmitted, disseminated, sold, published or circulated or otherwise used in any way whatsoever except as permitted herein. All trademarks, product names, whether or not appearing in large print or with the trademark symbol, are trademarks of Otonomy, its affiliates, related companies or its licensors or joint venture partners unless otherwise noted. The use of any Otonomy Content, except as permitted herein, is expressly prohibited and may be in violation of copyright law, trademark law and unfair competition laws. No license or right is intended to be conveyed to you under any trademark of Otonomy or any third party, whether by implication, estoppel or otherwise. Further, you agree not to remove, alter or obscure any intellectual property notices on any printouts, screen displays or copies thereof. You agree not to add any logos or other marks indicating origin or ownership or any data or content originally found thereon to any of the foregoing displays, printouts or copies thereof. All rights not expressly granted herein are reserved.

Links / Third Party Content

Otonomy may link this site to third party web sites. The links provided through this site are not under the control of Otonomy and are provided strictly for your convenience. Otonomy does not represent, warrant, or endorse such web sites, and is not responsible or liable for the accuracy, currency, completeness, availability or reliability of such web sites or the content, products or services obtained from such web sites. Otonomy shall have no liability for any damages or injuries of any kind arising from the content of or products or services obtained from such web sites. Otonomy is also not responsible or liable for any content on this site that has been provided by third parties. Such third party websites are not subject to these Terms of Use and our Privacy Policy and you are encouraged to review the terms of use and privacy policy of the applicable third party site.

Limitation of Liability

YOUR USE OF THIS SITE IS AT YOUR OWN RISK. TO THE FULLEST EXTENT PERMISSIBLE UNDER APPLICABLE LAW, OTONOMY AND ITS OFFICERS, DIRECTORS, EMPLOYEES OR AGENTS WILL NOT BE RESPONSIBLE OR LIABLE FOR ANY RISK OF LOSS OR DAMAGES OF ANY KIND ARISING OR RESULTING FROM THE USE OF THIS SITE, INCLUDING, BUT NOT LIMITED TO DIRECT, INDIRECT, INCIDENTAL, PUNITIVE, AND CONSEQUENTIAL DAMAGES.

Changes

Otonomy reserves the right to make changes to this site and these Terms of Use (including the Privacy Policy) at any time without notice. Your continued use of this site indicates your acceptance of any changes to the Terms of Use (including the Privacy Policy). You are encouraged to periodically review these Terms of Use (including the Privacy Policy) for any updates. The information on this site, including press releases, may be incomplete or may not be current. Otonomy expressly disclaims any obligation to update or correct information provided on this site. Otonomy makes no representations or warranties regarding the accuracy and completeness of this site, and does not assume any liability or responsibility for any errors or omissions on this site.

User Information

Except for the personally identifiable and non-personally identifiable information described in Otonomy’s Privacy Policy, or as may otherwise be required by law, any information that a user submits or transmits to Otonomy, through this site or through any other means, including but not limited to any data, questions, comments, suggestions, inventions, concepts, know-how, techniques or ideas, is submitted by the user without restriction, and will be treated as non-confidential and non-proprietary information. Otonomy shall have no obligation of any kind with respect to such information, and may use such information for any purpose whatsoever, including, but not limited to, reproduction, disclosure, transmission, publication, broadcast and display. Otonomy shall also be free to use all such information for any purpose whatsoever, including research and development, improvement, manufacturing, and commercialization of Otonomy’s current and future products using or incorporating such information. Otonomy reserves the right, and you agree that Otonomy may use and assign all information regarding your use of this site and all information provided by you in any manner consistent with these Terms of Use (including the Privacy Policy) and applicable law.

Void Where Prohibited

This site and its content are intended to comply with the laws and regulations in the U.S. Although the information on this site is accessible to users outside of the U.S., the information on this site pertaining to Otonomy products is intended for use only by residents of the U.S.

Privacy Policy

Otonomy respects the privacy of its users and has created a Privacy Policy that explains Otonomy policies with respect to personal information disclosed to Otonomy via this site. The Privacy Policy is hereby incorporated into these Terms of Service by this reference.

Indemnity

You agree to indemnify, defend and hold Otonomy, its officers, directors, employees, consultants and agents harmless from and against any and all claims, liabilities, losses, damages, and costs, including attorney’s fees, arising out of, resulting from or connected with your use or misuse of this site or its contents, including, without limitation, any violation of these Terms of Use.

Termination of Usage

We may terminate or suspend your access to all or part of this site, without notice, for any conduct that we, in our sole discretion, believe is disruptive to this site or is in violation of any applicable law or these Terms of Use.

Applicable Law

This site and all information provided on this site, including press releases, are created and controlled by Otonomy in the State of California, USA, and are intended for use only in accordance with applicable laws and regulations of the USA. The laws of the State of California, USA govern this site and its contents, and any disputes arising therefrom, without giving effect to any principles of conflicts of laws. No action arising under or relating to these Terms of Use may be brought by either party more than one year after the cause of action has occurred.

Arbitration and Jurisdiction

Except as set forth below, any controversy, dispute or claim of any nature whatsoever, arising out of, in connection with or in relation to these Terms of Use, or otherwise involving any party hereto, including any claim based on contract, tort or statute that may lawfully be arbitrated, and including the issue of arbitrability of any such disputes, will be exclusively resolved by final and binding arbitration. The American Arbitration Association (AAA) will administer the arbitration under its Commercial Arbitration Rules and the Supplementary Procedures for Consumer Related Disputes. The arbitration will be held in San Diego, CA, or any other location we agree to. Any interim or final relief or award granted by the Arbitrator, including without limitation any provisional relief, may be enforced, and final judgment upon any award or decision rendered by the Arbitrator may be entered and enforced, by any state or federal court having jurisdiction.

Either you or Otonomy may assert claims, if they qualify, in small claims court in San Diego, CA or any United States county where you live or work. Either party may bring a lawsuit solely for injunctive relief to stop unauthorized use or abuse of the site, or intellectual property infringement without first engaging in arbitration.You may only resolve disputes with us on an individual basis, and may not bring a claim as a plaintiff or a class member in a class, consolidated, or representative action. Class arbitrations, class actions, private attorney general actions, and consolidation with other arbitrations are not allowed.

In the event that the agreement to arbitrate is found not to apply to you or your claim, you and Otonomy agree that any judicial proceeding (other than small claims actions) will be brought in the federal or state courts in San Diego County. Both you and Otonomy consent to venue and personal jurisdiction there.

Miscellaneous

These Terms of Use, including our Privacy Policy, constitute the entire agreement between you and Otonomy and supersede any and all other agreements, representations, and understandings, whether written or oral regarding this site. These Terms of Use may not be modified or amended by you without the prior written consent of Otonomy. If any clause or provision set forth in these Terms of Use is determined to be illegal, invalid or unenforceable, then you understand and agree that the clause or provision so determined to be illegal, invalid or unenforceable shall be severable without affecting the enforceability of all remaining clauses and provisions. The headings used in these Terms of Use are for convenience only and are not to be used in determining the meaning or interpretation of these Terms of Use.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

OTIPRIO is contraindicated in patients with a history of hypersensitivity to ciprofloxacin, to other quinolones, or to any of the components of OTIPRIO.

WARNINGS AND PRECAUTIONS

Potential for Microbial Overgrowth: OTIPRIO may result in overgrowth of nonsusceptible bacteria and fungi. If such infections occur, institute alternative therapy.

ADVERSE REACTIONS

Adverse reactions (incidence at least 3%) that occurred in two Phase 3 trials with OTIPRIO vs sham were: nasopharyngitis (5% vs 4%), irritability (5% vs 3%), and rhinorrhea (3% vs 2%).

USE IN SPECIFIC POPULATIONS

Pediatric Use: The safety and effectiveness of OTIPRIO in infants below six months of age have not been established.

Indications and Usage

OTIPRIO® (ciprofloxacin otic suspension) 6% is a fluoroquinolone antibacterial indicated for the treatment of pediatric patients with bilateral otitis media with effusion undergoing tympanostomy tube placement.

Please see full Prescribing Information.