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Terms of Use

AGREEMENT BETWEEN USER AND ACERUS PHARMACEUTICALS CORPORATION

These Terms of Use apply to the Acerus Pharmaceuticals Corporation (“Acerus”) Web Site at natesto.com. Other sites owned and/or operated by Acerus may be subject to different Terms of Use.

The Acerus Web Site is offered to you conditioned on your acceptance without modification of the terms, conditions, and notices contained herein, as well as the Privacy Statement available at http://www.natesto.com/privacy-statement. Your use of the Acerus Web Site constitutes your agreement to all such terms, conditions, and notices. If you do not agree to such terms, conditions, and notices, you may not use the Web Site.

MODIFICATION OF THESE TERMS OF USE

Acerus reserves the right to change the terms, conditions, and notices under which the Acerus Web Site is offered, including but not limited to the charges associated with the use of the Acerus Web Site.

LINKS TO THIRD PARTY SITES

The Acerus Web Site may contain links to other Web Sites ("Linked Sites"). The Linked Sites are not under the control of Acerus and Acerus is not responsible for the contents of any Linked Site, including without limitation any link contained in a Linked Site, or any changes or updates to a Linked Site. Acerus is not responsible for webcasting or any other form of transmission received from any Linked Site. Acerus is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by Acerus of the site or any association with its operators.

NO UNLAWFUL OR PROHIBITED USE

As a condition of your use of the Acerus Web Site, you warrant to Acerus that you will not use the Acerus Web Site for any purpose that is unlawful or prohibited by these terms, conditions, and notices. You may not use the Acerus Web Site in any manner which could damage, disable, overburden, or impair the Acerus Web Site or interfere with any other party's use and enjoyment of the Acerus Web Site. You may not obtain or attempt to obtain any materials or information through any means not intentionally made available or provided for through the Acerus Web Sites.

HEALTH CARE INFORMATION

Any health care information included on the Acerus Web Site is not meant to replace the advice of medical professionals. The information provided on this site should not be used for diagnosis of any health condition—consult a medical professional for diagnosis and treatment options.

USE OF COMMUNICATION SERVICES

The Acerus Web Site may contain bulletin board services, chat areas, news groups, forums, communities, personal web pages, calendars, and/or other message or communication facilities designed to enable you to communicate with the public at large or with a group (collectively, "Communication Services"), you agree to use the Communication Services only to post, send and receive messages and material that are proper and related to the particular Communication Service. By way of example, and not as a limitation, you agree that when using a Communication Service, you will not:

  • Defame, abuse, harass, stalk, threaten or otherwise violate the legal rights (such as rights of privacy and publicity) of others.
  • Publish, post, upload, distribute or disseminate any inappropriate, profane, defamatory, infringing, obscene, indecent or unlawful topic, name, material or information.
  • Upload files that contain software or other material protected by intellectual property laws (or by rights of privacy of publicity) unless you own or control the rights thereto or have received all necessary consents.
  • Upload files that contain viruses, corrupted files, or any other similar software or programs that may damage the operation of another's computer.
  • Advertise or offer to sell or buy any goods or services for any business purpose, unless such Communication Service specifically allows such messages.
  • Conduct or forward surveys, contests, pyramid schemes or chain letters.
  • Download any file posted by another user of a Communication Service that you know, or reasonably should know, cannot be legally distributed in such manner.
  • Falsify or delete any author attributions, legal or other proper notices or proprietary designations or labels of the origin or source of software or other material contained in a file that is uploaded.
  • Restrict or inhibit any other user from using and enjoying the Communication Services.
  • Violate any code of conduct or other guidelines which may be applicable for any particular Communication Service.
  • Harvest or otherwise collect information about others, including e-mail addresses, without their consent.
  • Violate any applicable laws or regulations.

Acerus has no obligation to monitor the Communication Services. However, Acerus reserves the right to review materials posted to a Communication Service and to remove any materials in its sole discretion. Acerus reserves the right to terminate your access to any or all of the Communication Services at any time without notice for any reason whatsoever.

Acerus reserves the right at all times to disclose any information as necessary to satisfy any applicable law, regulation, legal process or governmental request, or to edit, refuse to post or to remove any information or materials, in whole or in part, in Acerus' sole discretion.

Always use caution when giving out any personally identifying information about yourself or your children in any Communication Service. Acerus does not control or endorse the content, messages or information found in any Communication Service and, therefore, Acerus specifically disclaims any liability with regard to the Communication Services and any actions resulting from your participation in any Communication Service. Managers and hosts are not authorized Acerus spokespersons, and their views do not necessarily reflect those of Acerus.

Materials uploaded to a Communication Service may be subject to posted limitations on usage, reproduction and/or dissemination. You are responsible for adhering to such limitations if you download the materials.

MATERIALS PROVIDED TO ACERUS OR POSTED AT ANY ACERUS WEB SITE

Acerus does not claim ownership of the materials you provide to Acerus (including feedback and suggestions) or post, upload, input or submit to any Acerus Web Site or its associated services (collectively "Submissions"). However, by posting, uploading, inputting, providing or submitting your Submission you are granting Acerus, its affiliated companies and necessary sublicensees permission to use your Submission in connection with the operation of their Internet businesses including, without limitation, the rights to: copy, distribute, transmit, publicly display, publicly perform, reproduce, edit, translate and reformat your Submission; and to publish your name in connection with your Submission.

No compensation will be paid with respect to the use of your Submission, as provided herein. Acerus is under no obligation to post or use any Submission you may provide and may remove any Submission at any time in Acerus’ sole discretion.

By posting, uploading, inputting, providing or submitting your Submission you warrant and represent that you own or otherwise control all of the rights to your Submission as described in this section including, without limitation, all the rights necessary for you to provide, post, upload, input or submit the Submissions.

LIABILITY DISCLAIMER

THE INFORMATION, SOFTWARE, PRODUCTS, AND SERVICES INCLUDED IN OR AVAILABLE THROUGH THE ACERUS WEB SITE MAY INCLUDE INACCURACIES OR TYPOGRAPHICAL ERRORS. CHANGES ARE PERIODICALLY ADDED TO THE INFORMATION HEREIN. ACERUS AND/OR ITS SUPPLIERS MAY MAKE IMPROVEMENTS AND/OR CHANGES IN THE ACERUS WEB SITE AT ANY TIME. ADVICE RECEIVED VIA THE ACERUS WEB SITE SHOULD NOT BE RELIED UPON FOR PERSONAL, MEDICAL, LEGAL OR FINANCIAL DECISIONS AND YOU SHOULD CONSULT AN APPROPRIATE PROFESSIONAL FOR SPECIFIC ADVICE TAILORED TO YOUR SITUATION.

ACERUS AND/OR ITS SUPPLIERS MAKE NO REPRESENTATIONS ABOUT THE SUITABILITY, RELIABILITY, AVAILABILITY, TIMELINESS, AND ACCURACY OF THE INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS CONTAINED ON THE ACERUS WEB SITE FOR ANY PURPOSE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ALL SUCH INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS ARE PROVIDED "AS IS" WITHOUT WARRANTY OR CONDITION OF ANY KIND. ACERUS AND/OR ITS SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS, INCLUDING ALL IMPLIED WARRANTIES OR CONDITIONS OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON-INFRINGEMENT.

TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, IN NO EVENT SHALL ACERUS AND/OR ITS SUPPLIERS BE LIABLE FOR ANY DIRECT, INDIRECT, PUNITIVE, INCIDENTAL, SPECIAL, CONSEQUENTIAL DAMAGES OR ANY DAMAGES WHATSOEVER INCLUDING, WITHOUT LIMITATION, DAMAGES FOR LOSS OF USE, DATA OR PROFITS, ARISING OUT OF OR IN ANY WAY CONNECTED WITH THE USE OR PERFORMANCE OF THE ACERUS WEB SITE, WITH THE DELAY OR INABILITY TO USE THE ACERUS WEB SITE OR RELATED SERVICES, THE PROVISION OF OR FAILURE TO PROVIDE SERVICES, OR FOR ANY INFORMATION, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS OBTAINED THROUGH THE ACERUS WEB SITE, OR OTHERWISE ARISING OUT OF THE USE OF THE ACERUS WEB SITE, WHETHER BASED ON CONTRACT, TORT, NEGLIGENCE, STRICT LIABILITY OR OTHERWISE, EVEN IF ACERUS OR ANY OF ITS SUPPLIERS HAS BEEN ADVISED OF THE POSSIBILITY OF DAMAGES. BECAUSE SOME STATES/JURISDICTIONS DO NOT ALLOW THE EXCLUSION OR LIMITATION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES, THE ABOVE LIMITATION MAY NOT APPLY TO YOU. IF YOU ARE DISSATISFIED WITH ANY PORTION OF THE ACERUS WEB SITE, OR WITH ANY OF THESE TERMS OF USE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USING THE ACERUS WEB SITE.

SERVICE CONTACT: IR@ACERUSPHARMA.COM

TERMINATION/ACCESS RESTRICTION

Acerus reserves the right, in its sole discretion, to terminate your access to the Acerus Web Site and the related services or any portion thereof at any time, without notice. General to the maximum extent permitted by law, this agreement is governed by the laws of Ontario, Canada and you hereby consent to the exclusive jurisdiction and venue of courts therein in all disputes arising out of or relating to the use of the Acerus Web Site.

Use of the Acerus Web Site is unauthorized in any jurisdiction that does not give effect to all provisions of these terms and conditions, including without limitation this paragraph. You agree that no joint venture, partnership, employment, or agency relationship exists between you and Acerus as a result of this agreement or use of the Acerus Web Site. Acerus’ performance of this agreement is subject to existing laws and legal process, and nothing contained in this agreement is in derogation of Acerus' right to comply with governmental, court and law enforcement requests or requirements relating to your use of the Acerus Web Site or information provided to or gathered by Acerus with respect to such use. If any part of this agreement is determined to be invalid or unenforceable pursuant to applicable law including, but not limited to, the warranty disclaimers and liability limitations set forth above, then the invalid or unenforceable provision will be deemed superseded by a valid, enforceable provision that most closely matches the intent of the original provision and the remainder of the agreement shall continue in effect. Unless otherwise specified herein, this agreement constitutes the entire agreement between the user and Acerus with respect to the Acerus Web Site and it supersedes all prior or contemporaneous communications and proposals, whether electronic, oral or written, between the user and Acerus with respect to the Acerus Web Site. A printed version of this agreement and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to this agreement to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form. It is the express wish to the parties that this agreement and all related documents be drawn up in English.

COPYRIGHT AND TRADEMARK NOTICES:

All contents of the Acerus Web Site are: © 2021 by Acerus and/or its suppliers. All rights reserved.

TRADEMARKS

The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

The example companies, organizations, products, people and events depicted herein are fictitious. No association with any real company, organization, product, person, or event is intended or should be inferred.

Any rights not expressly granted herein are reserved.

SEVERABILITY

These Terms of Use incorporate any notices contained on the Web Site and Privacy Statement and constitute the entire agreement between you and Acerus governing access to the Web Site. If any provision of these Terms of Use is held to be unlawful, void, unenforceable, or in conflict with another applicable agreement, then the provision shall be deemed severable from the remaining provisions and shall not affect their validity and enforceability.

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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 30 minutes after using 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
  • Nasal 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.

Store Natesto between 68°F to 77°F (20°C to 25°C).

Keep Natesto and all medicines out of the reach of children.

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, visit Natesto.com, or call 1-833-698-3786.

Indication

What is Natesto 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.

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.

Natesto is not meant for use in women.

Please see the Full Prescribing Information and Patient Information.

NATESTO® is a registered trademark of Acerus Biopharma Inc.

The Acerus Pharma logo is a trademark of Acerus Pharmaceuticals Corporation.

© Acerus Pharmaceuticals Corporation.

All other trademarks are the property of their respective owners.

NAT-US-0143  09/21