Aytu BioScience, Inc.
Online Terms of Use

These Online Terms of Use govern your access to websites controlled by Aytu BioScience, including its subsidiaries and affiliates, which link to these Online Terms of Use (together referred to as “Aytu BioScience websites”). These Online Terms of Use do not apply to Aytu BioScience websites that do not link to these Online Terms of Use, or to third-party websites to which Aytu BioScience websites may link. Your use of Aytu BioScience websites is subject to these Online Terms of Use and the Privacy Policy.

Without prejudice to your rights under applicable law, Aytu BioScience reserves the right to amend these Online Terms of Use to reflect technological advancements, legal and regulatory changes and good business practices. If Aytu BioScience changes these Online Terms of Use, an updated version of these Online Terms of Use will reflect those changes. By accessing or using the Aytu BioScience websites, you agree that you have read, understand, and agree to be bound to the current version of these Online Terms of Use which you may view when accessing the Aytu BioScience websites. If you disagree with these Online Terms of Use, or are dissatisfied with the Aytu BioScience websites, your sole and exclusive remedy is to discontinue using this Aytu BioScience website.

Disclaimers

You acknowledge and agree that:

Although we strive to provide on the Aytu BioScience websites the latest developments relating to our products and activities, and other information about Aytu BioScience, we do not warrant the accuracy, effectiveness, and suitability of any information contained in the Aytu BioScience websites. Each person assumes full responsibility and all risks arising from use of the Aytu BioScience websites. The information is presented “AS IS” and may include technical inaccuracies or typographical errors. Aytu BioScience reserves the right to make additions, deletions, or modifications to the information contained on the Aytu BioScience websites at any time without any prior notification.

AYTU BIOSCIENCE MAKES NO REPRESENTATIONS OR WARRANTIES OF ANY KIND OR NATURE WITH RESPECT TO THE INFORMATION OR CONTENT POSTED ON THE AYTU BIOSCIENCE WEBSITES. AYTU BIOSCIENCE HEREBY DISCLAIMS ALL REPRESENTATIONS AND WARRANTIES, WHETHER EXPRESS OR IMPLIED, CREATED BY LAW, CONTRACT OR OTHERWISE, INCLUDING, WITHOUT LIMITATION, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE OR NON-INFRINGEMENT. IN NO EVENT SHALL AYTU BIOSCIENCE BE LIABLE FOR ANY DAMAGES OF ANY KIND OR NATURE, INCLUDING, WITHOUT LIMITATION, DIRECT, INDIRECT, SPECIAL (INCLUDING LOSS OF PROFIT) CONSEQUENTIAL OR INCIDENTAL DAMAGES ARISING FROM OR IN CONNECTION WITH THE EXISTENCE OR USE OF THE AYTU BIOSCIENCE WEBSITES, AND/OR THE INFORMATION OR CONTENT POSTED ON THE AYTU BIOSCIENCE WEBSITES, REGARDLESS OF WHETHER AYTU BIOSCIENCE HAS BEEN ADVISED AS TO THE POSSIBILITY OF SUCH DAMAGES.

Aytu BioScience is not responsible, and provides no warranty whatsoever, for the accuracy, effectiveness, timeliness and suitability of any information or content obtained from third parties, including any hyperlinks to or from third-party sites. Except as otherwise provided on the Aytu BioScience websites, Aytu BioScience will not edit, censor, or otherwise control any content provided by third parties on any bulletin board, chat room or other similar forums posted on the Aytu BioScience websites. Such information should, therefore, be considered as suspect and is not endorsed by Aytu BioScience.

The Aytu BioScience websites may contain forward-looking statements that reflect Aytu BioScience’s current expectation regarding future events and business development. The forward-looking statements involve risks and uncertainties. Actual developments or results could differ materially from those projected and depend on a number of factors including, but not limited to, the success of current research programs, results of pending or future clinical trials, ongoing commercialization of its products, regulatory approvals of pharmaceuticals or medical devices, validity and enforcement of its patents, the stability of its commercial relationships, and the general economic conditions. Aytu BioScience intends to update the Aytu BioScience websites on a regular basis but assumes no obligation to update any of the content.

Your Use

You understand, acknowledge, and agree to the following:

By using the Aytu BioScience websites, you agree not to disrupt or intercept our electronic information posted on the Aytu BioScience websites or on any of our servers. You also agree not to attempt to circumvent any security features of the Aytu BioScience websites, and to abide by all applicable, local, state, federal and international laws, rules, and regulations.

You grant to Aytu BioScience the right to use all content you upload or otherwise transmit to the Aytu BioScience websites, subject to these Online Terms of Use and Aytu BioScience’s Privacy Policy in any manner Aytu BioScience chooses, including, but not limited to, copying, displaying, performing or publishing it in any format whatsoever, modifying it, incorporating it into other material, or making a derivative work based on it. To the extent allowed by applicable law you waive any moral rights you may have to content you upload or otherwise transmit to the Aytu BioScience websites (if any).

Except as expressly stated and agreed upon in advance by Aytu BioScience, no confidential relationship shall be established in the event that any user of the Aytu BioScience websites should make any oral, written or electronic communication to Aytu BioScience (such as feedback, questions, comments, suggestions, ideas, etc.). If any Aytu BioScience websites require or request that such information be provided, and that such information contains personal identifying information (e.g., name, address, phone number, email address), Aytu BioScience shall obtain, use, and maintain it in a manner consistent with our Privacy Policy. Otherwise, such communication and any information submitted therewith shall be considered non-confidential, and Aytu BioScience shall be free to reproduce, publish, or otherwise use such information for any purposes whatsoever including, without limitation, the research, development, manufacture, use, or sale of products incorporating such information. The sender of any information to Aytu BioScience is fully responsible for its content, including its truthfulness and accuracy, and its non-infringement of any other person’s proprietary or privacy rights.

Product Labeling

Product names, descriptions, and labeling may be of U.S. origin or of a third country’s origin which is not your country of residence. Products may not be available in all countries or may be available under a different brand name, in different strengths, or for different indications or intended uses. Many of the products listed are available only by prescription through your local health care professional. Except as expressly stated and agreed upon in advance by Aytu BioScience, no director, employee, agent, or representative of Aytu BioScience, its subsidiaries and affiliates are engaged in rendering medical advice, diagnosis, treatment, or other medical services that in any way create a physician-patient relationship through the Aytu BioScience websites.

Intellectual Property

The information, documents, and related graphics published in the Aytu BioScience websites (the “Information”) are the sole property of Aytu BioScience, except for information provided by third-party providers under contract to Aytu BioScience. Permission to use the Information is granted, provided that (1) the above copyright notice appears on all copies; (2) use of the Information is for informational and non-commercial or personal use only; (3) the Information is not modified in any way; and (4) no graphics available from this Aytu BioScience website are used separate from accompanying text. Aytu BioScience is not responsible for content provided by third-party providers, and you are prohibited from distribution of such material without permission of the owner of the copyright therein. Except as permitted above, no license or right, express or implied, is granted to any person under any patent, trademark or other proprietary right of Aytu BioScience. No use of any Aytu BioScience trademark, trade names, trade dress, and products in the Aytu BioScience websites may be made without the prior written authorization of Aytu BioScience, except to identify the product or services of the company.

Privacy and Security

Aytu BioScience is committed to safeguarding your privacy online. We understand the importance of privacy to our customers and visitors to the Aytu BioScience websites. Our use of personally identifiable information is governed by our Privacy Policy and by accessing and using the Aytu BioScience websites, you agree to be bound by that Privacy Policy.

You recognize and agree that when submitting your personally identifiable information to the Aytu BioScience websites, while Aytu BioScience has safeguards in place to prevent unauthorized access or interception, there is no absolute guarantee of security.

IN THE UNLIKELY EVENT OF AN INTERCEPTION OR UNAUTHORIZED ACCESS DESPITE OUR EFFORTS, AYTU BIOSCIENCE SHALL NOT BE RESPONSIBLE FOR SUCH INTERCEPTIONS OR UNAUTHORIZED ACCESS, OR ANY DIRECT, INDIRECT, SPECIAL, INCIDENTAL, OR CONSEQUENTIAL DAMAGES (INCLUDING LOST PROFITS) SUFFERED BY A CUSTOMER OR USER, EVEN IF AYTU BIOSCIENCE HAS PREVIOUSLY BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES, AYTU BIOSCIENCE DOES NOT WARRANT, EITHER EXPRESSLY OR IMPLIED, THAT THE INFORMATION PROVIDED BY ANY CUSTOMER SHALL BE FREE FROM INTERCEPTION OR UNAUTHORIZED ACCESS, AND DOES NOT PROVIDE ANY IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE. EACH CUSTOMER IS RESPONSIBLE FOR MAINTAINING THE CONFIDENTIALITY OF HIS OR HER OWN PASSWORD.

Limitation of Liability

Aytu BioScience does not assume any liability for the materials, information and opinions provided on, posted to, or otherwise available through, the Aytu BioScience websites. Reliance on these materials, information, and opinions is solely at your own risk. Aytu BioScience disclaims any liability for injury or damages resulting from the use of the Aytu BioScience websites, or the content contained thereon.

THE AYTU BIOSCIENCE WEBSITES, THE SITE CONTENT, AND THE PRODUCTS AND SERVICES PROVIDED ON OR AVAILABLE THROUGH THE AYTU BIOSCIENCE WEBSITES ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS, WITH ALL FAULTS. IN NO EVENT SHALL AYTU BIOSCIENCE OR ITS VENDORS, OR THEIR RESPECTIVE DIRECTORS, EMPLOYEES OR AGENTS (HEREINAFTER “AYTU BIOSCIENCE PARTIES”) BE LIABLE FOR ANY DAMAGES OF ANY KIND, UNDER ANY LEGAL THEORY, ARISING OUT OF, OR IN CONNECTION WITH YOUR USE OF, OR INABILITY TO USE, THE AYTU BIOSCIENCE WEBSITES, THE SITE CONTENT, ANY SERVICES PROVIDED ON OR THROUGH THE AYTU BIOSCIENCE WEBSITES, OR ANY LINKED SITE, INCLUDING ANY SPECIAL, INDIRECT, PUNITIVE, INCIDENTAL, EXEMPLARY OR CONSEQUENTIAL DAMAGES, INCLUDING, BUT NOT LIMITED TO, PERSONAL INJURY, LOST PROFITS OR DAMAGES RESULTING FROM DELAY, INTERRUPTION IN SERVICE, VIRUSES, DELETION OF FILES OR ELECTRONIC COMMUNICATIONS, OR ERRORS, OMISSIONS OR OTHER INACCURACIES IN THE AYTU BIOSCIENCE WEBSITES OR THE SITE CONTENT, WHETHER OR NOT THERE IS NEGLIGENCE BY AYTU BIOSCIENCE AND WHETHER OR NOT AYTU BIOSCIENCE HAS BEEN ADVISED OF THE POSSIBILITY OF ANY SUCH DAMAGES.

You agree that regardless of any applicable law to the contrary, you cannot file a claim or cause of action arising out of or related to the Aytu BioScience Websites or these Online Terms of Use more than one (1) year after such claim or cause of action arose.

PLEASE BE AWARE THAT ADDITIONAL LEGAL NOTICES, DISCLAIMERS, AND OTHER TERMS AND CONDITIONS MAY APPLY TO THE AYTU BIOSCIENCE WEBSITES.

General

You agree that these Online Terms of Use and the Privacy Policy describe the entire agreement between us with respect to its subject matter. The Aytu BioScience websites were created and are operated under the laws of the State of Delaware. The laws of the State of Delaware will control the terms provided in these Online Terms and Conditions, to the extent that the laws of the State of Delaware are not overridden by applicably mandatory law, e.g. consumer protection laws applying to you. If a court of competent jurisdiction finds that any provision of these Online Terms of Use is invalid or unenforceable, you agree that the other provisions of these Online Terms of Use will remain in full force and effect.

REFERENCES
1. NATESTO® (Prescribing Information). Englewood, CO: Aytu BioScience, Inc; 2016.

INDICATION

What is NATESTO® (testosterone) Nasal Gel?

NATESTO is a prescription medicine that contains testosterone and is used to treat adult males who have low or no testosterone due to certain medical conditions. Your doctor will test the testosterone level in your blood before you start and while you are using NATESTO.

INDICATION

What is NATESTO® (testosterone) Nasal Gel?

NATESTO is a prescription medicine that contains testosterone and is used to treat adult males who have low or no testosterone due to certain medical conditions. Your doctor will test the testosterone level in your blood before you start and while you are using NATESTO.

NATESTO should not be used by men with breast cancer or known or suspected prostate cancer. NATESTO should not be used by women.

It is not known if NATESTO is safe or effective to treat men who have low testosterone due to aging.

Safety and effectiveness of NATESTO have not been established in children younger than 18 years old and NATESTO should not be used by children. NATESTO use by children may affect bone growth.

NATESTO is a controlled substance (CIII) because it contains testosterone that can be a target for people who abuse prescription medicines. Keep your NATESTO in a safe place to protect it. Never give your NATESTO to anyone else, even if they have the same symptoms you have. Selling or giving away this medicine may harm others and is against the law.

Important Safety Information

Who should not use NATESTO?

Do not use NATESTO if you:

  • Are a man who has breast cancer
  • Have or might have prostate cancer
  • Are pregnant or may become pregnant or are breastfeeding. NATESTO may harm your unborn or breastfeeding baby.
  • Talk to your doctor before using NATESTO if you have any of the above conditions.

What should I tell my doctor before using NATESTO? 

Before using NATESTO, tell your doctor about all of your medical conditions, including if you:

  • Have or have had nose (nasal) or sinus problems or nasal or sinus surgery
  • Have had a broken nose (fracture) within the past 6 months
  • Have or have had a fracture of your nose that caused the inside of your nose to be crooked (deviated anterior nasal septum)
  • Have or have had problems with swelling of the lining of your nose (mucosal inflammatory disorder)
  • Have breast cancer
  • Have or might have prostate cancer
  • Have urinary problems due to an enlarged prostate
  • Have heart problems
  • Have liver or kidney problems
  • Have problems breathing while you sleep (sleep apnea)

Tell your doctor about all the medicines you take, including prescription and over‐the‐counter medicines, vitamins, or herbal supplements.

Using NATESTO  with certain other medicines can affect each other. Especially tell your doctor if you take:

  • Insulin
  • Medicines that decrease blood clotting
  • Corticosteroids

How should I use NATESTO?

  • Use NATESTO exactly as your doctor tells you to. Your doctor will tell you how much NATESTO to use and when to use it.
  • NATESTO is for use in your nose (intranasally) only.
  • NATESTO can be used with a type of nasal spray called sympathomimetic decongestants such as oxymetazoline. NATESTO should not be used with other nasal sprays. It is not known if NATESTO is safe and effective when used with other nasal sprays.

What are the possible side effects of NATESTO?

NATESTO may cause serious side effects, including:

  • Nose (nasal) problems. Signs and symptoms of nasal problems may include runny nose, congestion, sneezing, nosebleed, nasal discomfort, nasal scabbing, or nasal dryness.
  • If you already have enlargement of your prostate gland, your signs and symptoms can get worse while using NATESTO. This can include: increased urination at night, trouble starting your urine stream, having to pass urine many times during the day, having an urge that you have to go to the bathroom right away, having a urine accident, and being unable to pass urine or weak urine flow.
  • Possible increased risk of prostate cancer. Your doctor should check you for prostate cancer or any other prostate problems before you start and while you use NATESTO.
  • Changes in red blood cells.
  • Blood clots in your legs or lungs. Signs and symptoms of a blood clot in your legs can include leg pain, swelling, or redness. Signs and symptoms of a blood clot in your lungs can include difficulty breathing or chest pain.
  • Possible increased risk of heart attack or stroke.
  • In large doses, NATESTO may lower your sperm count.
  • Possible increased risk of liver problems. Signs and symptoms of liver problems may include: nausea or vomiting, yellowing of your skin or whites of your eyes, dark urine, or pain on the right side of your stomach area (abdominal pain).
  • Swelling of your ankles, feet, or body, with or without heart failure. This may cause serious problems for people who have heart, kidney, or liver disease.
  • Enlarged or painful breasts.
  • Problems breathing while you sleep (sleep apnea).

Call your doctor right away if you have any of the serious side effects listed above.

The most common side effects of NATESTO include:

  • Increased prostate specific antigen (a test used to screen for prostate cancer)
  • Headache
  • Runny nose
  • Nosebleeds
  • Nose pain
  • Sore throat, cough
  • Upper respiratory infection
  • Sinus infection
  • Nose scabs

Other side effects include more erections than normal for you or erections that last for a long time.

These are not all the possible side effects of NATESTO. Call your doctor for medical advice about side effects.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

For more information, please see Full Prescribing Information and Patient Information.