Terms of Use

Welcome to the Acrotech Biopharma, LLC. (“Acrotech”) Web Site and thank you for visiting.

The information provided on this Web Site is for general informational and educational use only and is subject to the following terms and conditions.

By accessing and using this Web Site located at http://khapzory.com/ (“Web Site”), you agree, without limitation or qualification, to be bound by these Terms of Use (“Terms” or “Agreement”) in effect at the time of each such access or other use and acknowledge that any other agreements between you and Acrotech concerning this Web Site are superseded to the extent they conflict with this Agreement. These Terms are a legal contract between you and Acrotech and govern your use of all the text, data, information, software, graphics, photographs and more that we may make available to you through our website (all of which are referred to in these Terms as this “Web Site”).

You also acknowledge that Acrotech may, from time to time, in its sole discretion and without notification to you, change these Terms, and such changes will be deemed effective upon posting. Continued use of this Web Site following the posting of an amended Terms of Use will indicate acceptance of such changes and therefore, you should review the Terms each time you visit or use this Web Site. If you do not agree to these Terms, do not use this Web Site. Like any other service, in spite of our best efforts, the information in this Web Site may become out-of-date over time. Nothing on this Web Site should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action.

READ THESE TERMS CAREFULLY BEFORE BROWSING THIS WEB SITE. USING THIS WEB SITE INDICATES THAT YOU HAVE BOTH READ AND ACCEPT THESE TERMS. YOU CANNOT USE THIS WEB SITE IF YOU DO NOT ACCEPT THESE TERMS.

General Use

By using this Web Site, you promise that you are at least 13 years of age. If you are not yet 18 years old, you must have the permission of your parent or legal guardian to use this Web Site and agree to its Terms, and who is willing be responsible for your use of this Web Site.

While Acrotech uses reasonable efforts to include accurate and up-to-date information in its Web Site, Acrotech accepts no liability or responsibility for any error or omissions in the content of this Web Site or for the accuracy or completeness or use of, nor any liability to update, the information contained on this Web Site. We make no guarantees regarding the availability of this Web Site and we reserve the right, within our sole discretion, to discontinue this Web Site. You agree that we will not be liable to you for any such discontinuance or modification of this Web Site. Any rights not expressly granted by these Terms are reserved by us.

This Web Site has been developed as a service of Acrotech. Like any other service, in spite of our best efforts the information in this Web Site may become out of date over time. Nothing on this Web Site should be construed as the giving of advice or the making of a recommendation and it should not be relied on as the basis for any decision or action. It is important that you rely only on the advice of a health care professional to advise you on your specific situation.

Medical Information

The health and medical information contained herein is provided for educational and informational purposes only and is not meant to be a substitute for advice offered by a doctor or other healthcare professional. If medical advice or services are desired, please consult your physician or healthcare provider.

Certain sections of this Web Site are intended for particular audiences including Prescribers, Patients, Pharmacists and Distributors. Such information is neither a substitute nor intended to be a substitute for the advice provided by a licensed healthcare professional. You should not use the information contained herein for diagnosing a health problem or disease. Users of this Web Site always should consult a licensed healthcare professional before using any prescription drug product discussed on this Web Site or any other website. Information on this Web Site regarding such products approved for marketing is qualified in its entirety by reference to the Full Prescribing Information for such products.

All decisions regarding patient care must be made with a healthcare provider, considering the unique characteristics of the patient.

While there may be information contained within this Web Site related to certain medical conditions and/or their treatment, should a medical condition exist, consult with your own physician or health care professional. THE CONTENT AVAILABLE THROUGH THE WEB SITE, OR COMMUNICATED TO YOU DIRECTLY THROUGH THE SERVICES, IS FOR INFORMATIONAL AND EDUCATIONAL PURPOSES ONLY AND IS NOT A SUBSTITUTE FOR MEDICAL JUDGMENT, ADVICE, DIAGNOSIS, OR TREATMENT OF ANY HEALTH CONDITION OR PROBLEM. You should not rely on information contained via the Web Site for diagnosing, treating, curing, preventing, managing or otherwise addressing health problems. Questions should be addressed to a physician or other health care professional. WE DO NOT, THROUGH THE WEB SITE OR OTHERWISE, PROVIDE MEDICAL ADVICE, MEDICAL PRESCRIPTIONS, TREATMENTS OR DIAGNOSTIC SERVICES. Your doctor or other health care professional, as a learned intermediary, is in the best position to assess, and provide information, about your medical condition and any treatment options. Use of the Web Site does not in and of itself create an express or implied physician-patient relationship. In using the Web Site, you agree that Acrotech is not, or will not be, liable or otherwise responsible for any decision made or any action taken or any action not taken due to your use of the Web Site or services. PLEASE CONSULT A HEALTHCARE PROVIDER FOR ALL MEDICAL ADVICE OR QUESTIONS.

Restrictions on Your Use

Acrotech Biopharma grants you a limited, personal, non-exclusive and non-transferable license to access and use this Web Site for noncommercial, personal purposes, provided that the materials are not modified in any way and all copyright and other proprietary notices contained on the provided materials are maintained and so long as you comply with these Terms. Such limited license shall enable you to use this Web Site only for individual informational purposes. This license shall not include any resale or commercial use of this Web Site or its contents; any derivative use of this Web Site or its contents; or any use of data mining, robots, or similar data gathering and extraction tools. Do not frame or utilize framing techniques to enclose any trademark, logo, or other proprietary information (including images, text, page layout, or form) of Acrotech or our affiliates without Acrotech’s prior express written consent. Unfortunately, if you breach any of these Terms the above license will terminate automatically and you must immediately destroy any downloaded or printed materials (and any copies thereof).

All content within this Web Site and any materials made available on these pages for downloading are the property of Acrotech and/or its affiliates or other third parties. This Agreement does not grant any license to modify or alter the materials on this Web Site that are viewed, downloaded, or otherwise accessed by you. You shall keep intact all proprietary notices, including copyright notices, contained on any downloadable materials. You shall be solely liable for any damages resulting from any infringement of copyright, trademark, or any other proprietary right, or any and all harm resulting from your use of this Web Site.

Intellectual Property

Any and all intellectual property rights associated with this Web Site, including, without limitation, any inventive concepts, know-how, publicity rights, trademarks, trade dress, trade secrets, copyrights, and patents (“Intellectual Property”) are the sole and exclusive property of Acrotech or third parties. Acrotech hereby authorizes you to copy materials published by Acrotech on this Web Site for non-commercial, personal use only, provided any copy of these materials that you make shall retain all copyright and other proprietary notices and any disclaimer contained thereon and on this Web Site. Nothing contained herein shall be construed as conferring by implication, estoppel or otherwise any license or any express or implied right to Acrotech’s or any third-party’s Intellectual Property. Except as otherwise expressly authorized by these Terms, you may not copy, reproduce, modify, lease, loan, sell, create derivative works from, upload, transmit, or distribute the Intellectual Property of this Web Site in any way without the express written consent of Acrotech or the express written consent of the appropriate third-party, as applicable. Acrotech neither warrants nor represents that the use of images or materials from this Web Site will not infringe upon the rights of third parties not owned by or affiliated with Acrotech.

Privacy Policy

We respect the information that you provide to us, and want you to fully understand exactly how we use that information. So, please review our Privacy Policy at https://www.khapzory.com/privacy-policy, which explains everything.

Except with regard to your personal information and certain other information about you subject to our Privacy Policy, any oral, written, or electronic response or communication made in any form, medium or manner by any user of this Web Site shall be deemed as non-confidential and non-proprietary. Acrotech shall not have any obligation of any kind with respect to such information and shall be free to use any ideas, concepts, know-how, or techniques contained in such communication without restriction for any purpose whatsoever. The sender of such information is fully responsible for its content, including, without limitation, its accuracy and truthfulness and its non-infringement of another party’s proprietary rights. The Acrotech Privacy Policy is incorporated into the Terms of this Agreement by this reference.

Third Party Websites and Links

This US-based Web Site may provide or include links to other websites, references or resources not affiliated with Acrotech or under Acrotech’s control and are provided merely for convenience. Acrotech has not reviewed the websites that may be linked to this Web Site and is not responsible for the content of any other website linked to this Web Site. Because we have no control over such sites and resources, you acknowledge and agree that Acrotech is not responsible for the availability or operation of such external sites, or resources, and Acrotech does not endorse and is not responsible or liable for any content, advertising, products, or other materials on or available from such sites or resources. Acrotech makes no representations or warranties of any kind with respect to any third-party site. Linking to any pages off this Web Site is at your own risk. Acrotech shall not be liable for any damages or injury arising from users’ access to such website. YOU FURTHER ACKNOWLEDGE AND AGREE THAT ACROTECH SHALL NOT BE RESPONSIBLE OR LIABLE, DIRECTLY OR INDIRECTLY, FOR ANY DAMAGE OR LOSS CAUSED OR ALLEGED TO BE CAUSED BY OR IN CONNECTION WITH USE OF OR RELIANCE ON ANY SUCH CONTENT, GOODS, OR SITES AVAILABLE ON OR THROUGH ANY SUCH SITE OR RESOURCE.

Acrotech prohibits caching of any portion of this Web Site and any unauthorized hypertext links to this Web Site. Acrotech reserves the right to disable any unauthorized links or frames. If you desire to provide a hyperlink from your website to Acrotech’s Web Site, you must contact Acrotech to discuss mutually agreeable terms for such hyperlink.

Disclaimer of Warranties

ACROTECH MAKES NO WARRANTY OF ANY KIND REGARDING THIS WEB SITE AND/OR ANY MATERIALS PROVIDED ON THIS WEB SITE, ALL OF WHICH ARE PROVIDED ON AN “AS IS” AND “WITH ALL FAULTS” ON “AS AVAILABLE” BASIS. ACROTECH DOES NOT WARRANT THE ACCURACY, COMPLETENESS, CURRENCY, OR RELIABILITY OF ANY OF THE CONTENT OR DATA FOUND ON THIS WEB SITE AND EXPRESSLY DISCLAIMS ALL WARRANTIES, INCLUDING IMPLIED OR STATUTORY WARRANTIES OF MERCHANTABILITY, ANY EXPRESS WARRANTY, FITNESS FOR A PARTICULAR USE OR PURPOSE, TITLE, AND NONINFRINGEMENT, AND THOSE ARISING BY STATUTE OR OTHERWISE IN LAW OR FROM A COURSE OF DEALING OR USAGE OF TRADE. ACROTECH DOES NOT WARRANT THAT THIS WEB SITE, ITS SERVERS, OR ANY E-MAIL SENT FROM IT ARE FREE OF VIRUSES OR OTHER HARMFUL COMPONENTS. SOME STATES DO NOT ALLOW THE DISCLAIMER OF IMPLIED WARRANTIES, SO THE FOREGOING DISCLAIMER MAY NOT APPLY TO YOU. THIS WARRANTY GIVES YOU SPECIFIC RIGHTS, WHICH VARY FROM STATE TO STATE. THIS MEANS THAT WE DO NOT PROMISE YOU THAT THE WEB SITE IS FREE OF PROBLEMS.

Without limiting what we just stated, Acrotech makes no warranty that this Web Site will meet your requirements or that this Web Site will be uninterrupted, timely, secure, or error free or that defects in this Web Site will be corrected. Acrotech makes no warranty as to any results that come from the use of this Web Site or as to the accuracy or reliability of any information obtained through this Web Site. No advice or information, whether oral or written, obtained by you through this Web Site or from Acrotech shall create any warranty. Acrotech disclaims all equitable indemnities.

Limitations of Liability

Acrotech provide the contents of this Web Site for informational purposes and for your general interest only. By using the Web Site, you hereby agree not to rely on any of the information contained herein.

UNDER NO CIRCUMSTANCES SHALL ACROTECH BE LIABLE FOR YOUR RELIANCE ON ANY SUCH INFORMATION NOR SHALL ACROTECH BE LIABLE FOR DAMAGES OF ANY KIND, INCLUDING, WITHOUT LIMITATION, ANY DIRECT, INCIDENTAL, SPECIAL CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES THAT RESULT FROM THE USE OF, OR THE INABILITY TO USE, THE MATERIALS IN THIS SITE OR THE MATERIALS IN ANY SITE WHICH MAY BE LINKED TO THIS SITE, EVEN IF ACROTECH OR A ACROTECH AUTHORIZED REPRESENTATIVE HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. FURTHER, ACROTECH ASSUMES NO RESPONSIBILITY, AND SHALL NOT BE LIABLE, FOR ANY DAMAGES TO, OR VIRUSES THAT MAY INFECT, YOUR COMPUTER EQUIPMENT OR OTHER PROPERTY ON ACCOUNT OF YOUR ACCESS TO, USE OF, OR BROWSING IN THIS WEB SITE OR YOUR DOWNLOADING OF ANY MATERIALS, DATA, TEXT, IMAGES, VIDEO, OR AUDIO FROM THE WEB SITE. IN NO EVENT SHALL ACROTECH BE LIABLE FOR ANY INJURY, LOSS, CLAIM, DAMAGE, OR ANY SPECIAL, EXEMPLARY, EXTRAORDINARY, PUNITIVE, DIRECT, INDIRECT, INCIDENTAL, OR CONSEQUENTIAL DAMAGES OF ANY KIND (INCLUDING, BUT NOT LIMITED TO, LOSS OF DATA, REVENUE, LOST PROFITS OR LOST SAVINGS), WHETHER BASED IN CONTRACT, TORT, STRICT LIABILITY, OR OTHERWISE, WHICH ARISES OUT OF OR IS IN ANY WAY CONNECTED WITH ANY ACCESS TO OR USE OF THIS WEB SITE OR CONTENT FOUND THEREIN, REGARDLESS OF WHETHER YOU HAVE BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. APPLICABLE LAW MAY NOT ALLOW THE LIMITATION OR EXCLUSION OF LIABILITY OR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE ABOVE LIMITATION OR EXCLUSION MAY NOT APPLY TO YOU. IN NO EVENT SHALL ACROTECH’S TOTAL LIABILITY TO YOU FOR ALL DAMAGES, LOSSES, AND CAUSES OF ACTION WHETHER THE CAUSE OF ACTION IS IN CONTRACT, TORT (INCLUDING, BUT NOT LIMITED TO, NEGLIGENCE) OR OTHERWISE EXCEED THE AMOUNT PAID BY YOU, IF ANY, FOR ACCESSING THIS SITE.

Local Laws

We control and operate this Web Site from our headquarters in the United States of America and this Web Site may not be appropriate or available for use in other locations. If you use this Web Site outside the United States of America, you are solely responsible for following applicable local laws.

This Terms of Use Agreement and your use of this Web Site shall be governed by the laws of the United States and the State of Delaware without regard to the choice or conflicts of law provisions. Any legal action or proceeding arising from or relating to your access or use of this Web Site shall be brought exclusively in a federal or state court of proper jurisdiction in the State of Delaware. Foreign laws do not apply. If any of these Terms are deemed inconsistent with applicable law, then such term(s) shall be interpreted to reflect the intentions of the parties, and no other terms will be modified. By choosing not to enforce any of these Terms, Acrotech is not waiving its rights. These Terms are the entire agreement between you and Acrotech and, therefore, supersede all prior or contemporaneous negotiations, discussions or agreements between you and Acrotech about this Web Site. The proprietary rights, disclaimer of warranties, representations made by you, indemnities, limitations of liability and general provisions shall survive any termination of these Terms.

Software from this Web Site is further subject to United States export controls. No software from this Web Site may be downloaded or otherwise exported or re-exported (i) into (or to a national or resident of) Cuba, Iraq, Libya, North Korea, Iran, Syria or any other country subject to United States export control restrictions; or (ii) to anyone on the U.S. Treasury Department’s list of Specially Designated Nationals or the U.S. Commerce Department’s Table of Denial Orders. By downloading or using the Software, you represent and warrant that you are not located in, under the control of, or a national or resident of any such country or on any such list.

Feedback Received

Any submissions by you to Acrotech (e.g., comments, questions, suggestions, materials – collectively, “Feedback”) no matter how submitted, (e.g., call, fax, email) will be treated as both non-confidential and non-proprietary. You hereby assign all right, title, and interest in, and Acrotech is free to use, without any attribution or compensation to you, any ideas, know-how, concepts, techniques, or other intellectual property and proprietary rights contained in the Feedback, whether or not patentable, for any purpose whatsoever, including but not limited to, developing, manufacturing, having manufactured, licensing, marketing, and selling, directly or indirectly, products and services using such Feedback. You understand and agree that Acrotech is not obligated to use, display, reproduce, or distribute any such ideas, know-how, concepts, or techniques contained in the Feedback, and you have no right to compel such use, display, reproduction, or distribution.

Forward-Looking Statements

This Web Site may contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and in reliance upon the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on the beliefs Acrotech’s management as well as assumptions made by and information currently available to Acrotech’s management. Readers should not put undue reliance on these forward-looking statements. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Acrotech’s actual results may differ materially from the results projected in the forward-looking statements. Factors that might cause such a difference include, but are not limited to, those discussed in the documents and reports filed by Acrotech from time to time with the Securities and Exchange Commission, specifically the most recent Form 10-K and 10-Q. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this Web Site except as required by law.

This Agreement was last modified and is effective as of November 5, 2018.

Indications and Usage

KHAPZORY^TM is a folate analog indicated for:

Rescue after high-dose methotrexate therapy in patients with osteosarcoma.
Diminishing the toxicity associated with overdosage of folic acid antagonists or impaired methotrexate elimination.
Treatment of patients with metastatic colorectal cancer in combination with fluorouracil.

Limitations of Use

KHAPZORY is not indicated for the treatment of pernicious anemia and megaloblastic anemia secondary to lack of vitamin B₁₂ because of the risk of progression of neurologic manifestations despite hematologic remission.

Important Safety Information

Contraindications

KHAPZORY is contraindicated in patients who have had severe hypersensitivity to leucovorin products, folic acid, or folinic acid.

Warnings and Precautions

Increased gastrointestinal toxicities with fluorouracil: Gastrointestinal toxicities, including stomatitis and diarrhea, occur more commonly and may be of greater severity and of prolonged duration. Deaths from severe enterocolitis, diarrhea, and dehydration have occurred in elderly patients receiving weekly d,l-leucovorin and fluorouracil. Do not initiate or continue therapy with KHAPZORY and fluorouracil in patients with symptoms of gastrointestinal toxicity until those symptoms have resolved. Monitor patients with diarrhea until it has resolved as rapid deterioration leading to death can occur.
Drug interaction with trimethoprim-sulfamethoxazole: Concomitant use of d,l-leucovorin with trimethoprim-sulfamethoxazole for the acute treatment of Pneumocystis jiroveci pneumonia in patients with HIV infection increased treatment failure and morbidity.

Adverse Reactions

The most common adverse reactions (≥20%) in patients receiving high-dose methotrexate therapy with levoleucovorin rescue were stomatitis (38%) and vomiting (38%).
The most common adverse reactions (>50%) in patients receiving levoleucovorin in combination with fluorouracil for metastatic colorectal cancer were stomatitis (72%), diarrhea (70%), and nausea (62%).

Drug Interactions

Leucovorin products increase the toxicity of fluorouracil.

Use in Specific Populations

Levoleucovorin is administered in combination with methotrexate or fluorouracil, which can cause embryo-fetal harm. Refer to methotrexate and fluorouracil prescribing information for additional information.

Please click here to see full Prescribing Information for KHAPZORY.

ISI-PP-KAP-00-0001

Reporting of Suspected Adverse Reactions

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.