Terms and conditions of use for the Divigel® website

1. Terms 
By accessing the Divigel.com website provided by Vertical Pharmaceuticals, LLC (“Vertical Pharmaceuticals”), you are agreeing to be bound by these website Terms and Conditions of Use, which constitute the agreement that governs your use of the Divigel.com website. You should carefully read these Terms and Conditions of Use before using the site. If you do not agree to be bound by these terms of use, you should immediately exit the site.

2. User Eligibility; Consent 
The Divigel.com website is provided by Vertical Pharmaceuticals solely for use within the United States. Vertical Pharmaceuticals makes no representations or warranty that the Divigel.com website is usable and accurate outside of the United States. The Divigel.com website is not intended for use by children under the age of 13. Vertical Pharmaceuticals will not knowingly collect information about children under the age of 13 and will otherwise comply with the Children’s Online Privacy Act. Any user of the website should monitor the use of the website by children under their care and ensure that those children are aware of the dangers of providing information about themselves over the Internet.

3. License and Site Access
Vertical Pharmaceuticals hereby grants you permission to access and make personal, noncommercial use of the Divigel.com website. You may view, copy, print and distribute limited quantities of material from the website, so long as the material is used by you solely for informational, noncommercial purposes. Your permission to access and use the website will be deemed automatically to have been terminated, effective immediately, should you breach these Terms and Conditions of Use. Any rights not expressly granted to you by these Terms and Conditions of Use are expressly reserved by Vertical Pharmaceuticals.

4. Intellectual Property 
All intellectual property associated with the Divigel.com website, including, without limitation, its content, trademarks, service marks, trade dress and other proprietary intellectual property appearing on the website or referenced therein, are the sole property of Vertical Pharmaceuticals. Any rights associated with any such item of intellectual property are retained by its owner and protected by applicable law. These Terms and Conditions of Use expressly prohibit any use of any intellectual property associated with the website except as expressly specified in these Terms and Conditions of Use or elsewhere on the website.

5. Product and Service Information 
The Divigel.com website provides users with information regarding Vertical Pharmaceuticals’ Divigel® products and services. Periodically, Vertical Pharmaceuticals may add new features or information on the website, all of which will be subject to these Terms and Conditions of Use. You are encouraged to periodically review the current version of these Terms and Conditions of Use. Vertical Pharmaceuticals shall have no responsibility for errors of any kind in connection with the Divigel.com website. Errors and the consequences of those errors may include, without any limitation, any of the following: technical, typographical, or photographic errors. Vertical Pharmaceuticals does not warrant that any of the materials on its website are accurate, complete, or current. Vertical Pharmaceuticals may make changes to the materials contained on its website at any time without notice. Vertical Pharmaceuticals does not, however, make any commitment to update the materials.

6. No Warranty 
The Divigel.com website (including any content or information contained within it), any other Vertical Pharmaceuticals website, and any linked website, is provided “as is” and on an “as available” basis. AS TO THE SITE, AND TO ANY OTHER SUCH Vertical Pharmaceuticals WEBSITE AND LINKED WEBSITE, TO THE FULLEST EXTENT PERMITTED BY LAW, Vertical Pharmaceuticals EXPRESSLY DISCLAIMS ALL EXPRESS OR IMPLIED WARRANTIES, INCLUDING, WITHOUT LIMITATION, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FIRMNESS FOR A PARTICULAR PURPOSE, AND NON-INFRINGEMENT.

You assume total responsibility for your use of the Divigel.com website and any linked website. Any material downloaded or otherwise obtained through your use of the website is so obtained at your own discretion and risk. Vertical Pharmaceuticals will not be responsible for any damage to your computer system or loss of data that results from so obtaining any such material.

7. Limitation of Liability
IN NO EVENT SHALL Vertical Pharmaceuticals, ITS RELATED ENTITIES, SUBSIDIARIES, JOINT VENTURES, PARTNERS, OFFICERS, DIRECTORS OR EMPLOYEES BE LIABLE FOR ANY DIRECT, INDIRECT, COMPENSATORY, SPECIAL, INCIDENTAL, PUNITIVE OR CONSEQUENTIAL DAMAGES WHICH MAY ARISE, DIRECTLY OR INDIRECTLY, FROM THE ACCESS TO THE DIVIGEL.COM WEBSITE, FROM THE USE OF IT, FROM THE INABILITY TO USE IT, THROUGH THE AUTHORIZED DOWNLOADING OF ANY CONTENT (INCLUDING, WITHOUT LIMITATION, DATA, TEXT, IMAGES, VIDEO, OR AUDIO FROM THE WEBSITE) OR IN CONNECTION WITH ANY VIRUSES, BUGS, ACTION OR INACTION OF ANY COMPUTER SYSTEM, TELEPHONE LINE, HARDWARE, SOFTWARE OR PROGRAM MALFUNCTION, OR ANY OTHER ERROR, FAILURE OR DELAY IN DATA TRANSMISSION OR NETWORK CONNECTION EVEN IF ADVISED OF THE POSSIBILITY OF THAT DAMAGE. Vertical Pharmaceuticals has no liability for the deletion of any communications or information collected, maintained, or transmitted by the Divigel.com website or the failure to store any information, including personalized settings. Vertical Pharmaceuticals has no liability with respect to any information posted by users on chat rooms, bulletin boards or any other user forum.

8. Links 
Vertical Pharmaceuticals is not responsible for the contents of any sites linked to the Divigel.com website. The inclusion of any link does not imply endorsement by Vertical Pharmaceuticals of the site. Use of any such linked website is at your own risk.

9. Site Terms of Use Modifications 
Vertical Pharmaceuticals may revise these Terms and Conditions of Use for the Divigel.com website at any time without notice. By using this website, you are agreeing to be bound by the then current version of these Terms and Conditions of Use.

10. Governing Law 
Any claim relating to Vertical Pharmaceuticals’ website shall be governed by the laws of the State of New Jersey without regard to its conflict of law provisions.

Privacy Policy 
Your privacy is very important to us. The current privacy policy for Vertical Pharmaceuticals may be viewed at http://verticalpharma.com/privacy.

We are committed to conducting our business in accordance with these principles in order to ensure that the confidentiality of personal information is protected and maintained.

Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

Important Safety Information for Healthcare Providers

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

See Full Prescribing Information for complete Boxed Warning

Estrogen-Alone Therapy
  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
  • The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older
Estrogen Plus Progestin Therapy
  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
  • The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI estrogen plus progestin study reported increased risks of invasive breast cancer
  • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Divigel® should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Divigel®; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy.

Estrogens increase the risk of gallbladder disease.

Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.

Monitor thyroid function in women on thyroid replacement therapy.

The most common adverse reactions (incidence ≥ 5 percent) are breast tenderness, metrorrhagia, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection.

Patients should be started with the lowest effective dose and the dose should be evaluated periodically.

Alcohol-based gels are flammable. Patients should avoid fire, flame or smoking until the gel has dried.

Please see Full Prescribing Information, including Boxed Warning and Patient Counseling Information. For more information, call 732-721-0070 or visit www.divigel.com.

You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.

Important Safety Information & Indication
Divigel® (estradiol gel) 0.1% is indicated for the treatment of moderate to severe vasomotor symptoms due to menopause.

Important Safety Information for Healthcare Providers

WARNING: ENDOMETRIAL CANCER, CARDIOVASCULAR DISORDERS, BREAST CANCER and PROBABLE DEMENTIA

See Full Prescribing Information for complete Boxed Warning

Estrogen-Alone Therapy
  • There is an increased risk of endometrial cancer in a woman with a uterus who uses unopposed estrogens
  • Estrogen-alone therapy should not be used for the prevention of cardiovascular disease or dementia
  • The Women’s Health Initiative (WHI) estrogen-alone substudy reported increased risks of stroke and deep vein thrombosis (DVT)
  • The WHI Memory Study (WHIMS) estrogen-alone ancillary study of the WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age or older
Estrogen Plus Progestin Therapy
  • Estrogen plus progestin therapy should not be used for the prevention of cardiovascular disease or dementia
  • The WHI estrogen plus progestin substudy reported increased risks of stroke, DVT, pulmonary embolism (PE), and myocardial infarction (MI)
  • The WHI estrogen plus progestin study reported increased risks of invasive breast cancer
  • The WHIMS estrogen plus progestin ancillary study of WHI reported an increased risk of probable dementia in postmenopausal women 65 years of age and older

Divigel® should not be used in women with undiagnosed abnormal genital bleeding; known, suspected, or history of breast cancer; known or suspected estrogen-dependent neoplasia; active DVT, PE, or history of these conditions; active arterial thromboembolic disease or a history of these conditions; known anaphylactic reaction or angioedema to Divigel®; known liver impairment or disease; known protein C, protein S, or antithrombin deficiency, or other known thrombophilic disorders; or known or suspected pregnancy.

Estrogens increase the risk of gallbladder disease.

Discontinue estrogen if severe hypercalcemia, loss of vision, severe hypertriglyceridemia or cholestatic jaundice occurs.

Monitor thyroid function in women on thyroid replacement therapy.

The most common adverse reactions (incidence ≥ 5 percent) are breast tenderness, metrorrhagia, vaginal mycosis, nasopharyngitis, and upper respiratory tract infection.

Patients should be started with the lowest effective dose and the dose should be evaluated periodically.

Alcohol-based gels are flammable. Patients should avoid fire, flame or smoking until the gel has dried.

Please see Full Prescribing Information, including Boxed Warning and Patient Counseling Information. For more information, call 732-721-0070 or visit www.divigel.com.

You are encouraged to report negative side effects to Vertical Pharmaceuticals, LLC at 1-877-95-VERTI (1-877-958-3784), or to the FDA by visiting www.fda.gov/medwatch or calling 1-800-FDA-1088.