IBSA PHARMA INC. WEB SITE TERMS OF USE

(Updated and Effective: October 2018)

USE OF SITES

IBSA Pharma Inc. (“IBSA”” “we,” “us,” or “our”) owns and operates various websites (collectively, the “Sites”). The IBSA Sites are intended for lawful use by U.S. adults only and are intended to comply with U.S. laws and regulations. All information provided on these Sites is for general informational and educational purposes only. Certain sections of these Sites, or certain Sites, may be intended for use by health care professionals only. In those cases, health care professionals will be asked to self-identify before proceeding to such pages or Sites. By browsing the Sites, you acknowledge that you have read, understood, and agree to be legally bound by the terms and conditions of these Terms of Use (collectively, these “Terms of Use”). If you do not agree to any of these terms, then please do not use the Sites. We may change the terms and conditions of these Terms of Use from time to time with or without notice to you.

PRIVACY

IBSA is committed to privacy for our web site users. Please see IBSA’s Privacy Policy, the terms of which are incorporated into these Terms of Use, for more information.

MEDICAL INFORMATION

THE SITES DO NOT PROVIDE MEDICAL ADVICE. The Sites and the Content are provided for informational purposes only and are not intended as a substitute for professional medical advice, diagnosis, or treatment. The products listed are available upon prescription from a medical doctor or qualified medical professional only, and not all such products may be available in all countries. You should not use the information on the Sites for diagnosing or treating a medical or health condition. You should always obtain complete medical information about your medical condition and prescription medicines (including their uses and possible adverse effects) by discussing the appropriate use of any medicine(s) directly with your prescribing physician or, where appropriate, other medical advisor. Medical professionals may obtain complete medical information from the product's information leaflet. Information on these products may vary by country. Never disregard professional medical advice or delay in seeking it because of something made available to you on the Sites, or the Content. If you think you may have a medical emergency, call your doctor or 911 immediately. Reliance on the Sites, and the Content is solely at your own risk. IBSA makes no representations or warranties with respect to any information offered or provided on or through any Site regarding treatment, action, or application of medication.

CONTENT

IBSA will use reasonable efforts to include current, accurate content on the Sites, but makes no warranties or representations of any kind as to its accuracy, currency or completeness. Your access and use of the Sites and the content herein is undertaken at your own risk and is expressly subject to these Terms of Use.

LINKS TO THE SITES

IBSA has not reviewed any or all of the third-party websites which contain links to the Sites and is not responsible for the content of any such off-site pages or any other sites linked to the Sites. If you wish to link your website to the Sites, you may only link to the home page. You may not link to any other pages within the Sites without the prior written consent of IBSA. Quotation or use of one or more portions of the Sites in the site of any third parties without written consent is likewise prohibited.

LINKS TO THIRD PARTY SITES

The Sites may contain links to other websites (“Linked Sites”) or sources located on servers maintained by third parties over which IBSA has no control. IBSA 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. IBSA is not responsible for webcasting or any other form of transmission received from any Linked Site. Third party linked sites and their contents should not be attributed to IBSA (or any of its affiliated companies) in any manner. IBSA has not attempted to verify the truth or accuracy of any third party or content and does not make any representations or warranties about them. IBSA is providing these links to you only as a convenience, and the inclusion of any link does not imply endorsement by IBSA of the Sites or any association with its operators. If you decide to access any of the third-party sites linked to the Sites, you do so entirely at your own risk.

POSTING TO THE SITES

Although IBSA may from time to time monitor or review discussions, chats, postings, transmissions, message boards, and the like on the Sites, IBSA is under no obligation to do so and assumes no responsibility or liability arising from the content of any such locations nor for any error, defamation, libel, slander, omission, falsehood, promotional materials, obscenity, pornography, profanity, danger, privacy disclosure or inaccuracy contained in any information within such locations on the Sites. You are prohibited from posting or transmitting any unlawful, promotional, threatening, libelous, defamatory, obscene, scandalous, inflammatory, pornographic, or profane material or any material that could constitute or encourage conduct that would be considered a criminal offense, give rise to civil liability, or otherwise violate any law. IBSA will fully cooperate with any law enforcement authorities or court order requesting or directing IBSA to disclose the identity of anyone posting any such information or materials.

USE OF CONTENT

The Sites contain materials, such as software, text, graphics, images, sound recordings, audiovisual works, and other material provided by or on behalf of IBSA (collectively referred to as the “Content”). The Content may be owned by us or by third parties. The Content is protected under both United States and foreign copyright laws. Unauthorized use of the Content may violate copyright, trademark, and other laws.

You may use Site Content for your personal use for non-commercial purposes, but no modification or further reproduction of content is permitted. You must retain all copyright and other proprietary notices contained in the original Content on any copy you make of the Content. You may not sell, transfer, assign, license, sublicense, or modify the Content or reproduce, display, publicly perform, make a derivative version of, distribute, copy, download, reproduce, delete, republish, retransmit, display, or otherwise use the Content in any way for any public or commercial purpose. The use or posting of the Content on any other website or in a networked computer environment for any purpose is expressly prohibited. You should assume that everything you see or read on the Sites is copyrighted unless otherwise noted and may not be used except as provided in these Terms of Use or in the text on the Sites without the written permission of IBSA. Except as otherwise permitted in this paragraph, IBSA neither warrants nor represents that your use of materials displayed on the Site will not infringe rights of third parties not owned by or affiliated with IBSA. With the exception of the foregoing limited authorization, no license to or right in the Content contained on the Sites, or any copyright of IBSA or of any other party is granted or conferred to you.

TRADEMARKS/PROPRIETARY RIGHTS

You should assume that all product names appearing on the Sites, whether or not appearing in large print, italics or with the trademark symbol are trademarks of IBSA. The names, trademarks, service marks, trade names, trade dress, logos and IBSA products appearing on the Sites, including the “IBSA” logo (“IBSA Trademarks”) used and displayed on the Sites are registered and unregistered trademarks or service marks of IBSA or its subsidiaries or affiliates. Other company, product, and service names located on the Sites may be trademarks or service marks owned by others (the “Third-Party Trademarks”, and, collectively with the IBSA Trademarks, the “Trademarks”). These trademarks are protected in the United States and internationally and may not be used for advertising or publicity purposes, or to indicate any affiliation with or endorsement by IBSA, except with the express written permission of IBSA. Nothing on the Sites should be construed as granting, by implication, estoppel, or otherwise, any license or right to use the Trademarks, without our prior written permission specific for each such use. Use of the Trademarks as part of a link to or from any site is prohibited unless establishment of such a link is approved in advance by us in writing. All goodwill generated from the use of the IBSA Trademarks inures to our benefit.

IBSA is licensed to use all intellectual property in the content of this Site and reserves the right to pursue any intellectual property infringement in the courts of the country where IBSA suffers damage. No license is granted to you to use any trademark of IBSA or its affiliates. You shall not assert any claim or ownership to any such trademarks.

NO CONFIDENTIALITY

No confidential relationship shall be established in the event that any user of the Sites should make any oral, written or electronic response to IBSA. Although we encourage you to e-mail us, we do not want you to, and you should not, e-mail us any content that contains confidential information. Anything you transmit or post, including but not limited to feedback, questions, comments, suggestions, shall be considered non-confidential and shall become the property of IBSA or its affiliates. IBSA 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

DISCLAIMER OF WARRANTIES

IBSA MAKES NO REPRESENTATIONS OR WARRANTIES ABOUT THE SUITABILITY, RELIABILITY, AVAILABILITY, TIMELINESS, COMPLETENESS AND ACCURACY OF THE INFORMATION, CONTENT, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS CONTAINED ON SITES FOR ANY PURPOSE. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, ALL SUCH INFORMATION, CONTENT, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS ARE PROVIDED “AS IS” WITHOUT WARRANTY OR CONDITION OF ANY KIND EITHER EXPRESS OR IMPLIED. IBSA AND/OR ITS SUPPLIERS HEREBY DISCLAIM ALL WARRANTIES AND CONDITIONS WITH REGARD TO THIS INFORMATION, CONTENT, SOFTWARE, PRODUCTS, SERVICES AND RELATED GRAPHICS, INCLUDING ALL EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, TITLE AND NON- INFRINGEMENT.

LIMITATION OF LIABILITY

Neither IBSA nor any party involved in creating, producing or delivering the Sites shall be liable for any damages, including without limitation, direct, incidental, consequential, indirect or punitive damages, arising out of access to, use of or inability to use the Sites, or any errors or omissions in the content thereof. This limitation includes damages to, or for any viruses that infect, your computer equipment.

SOME JURISDICTIONS DO NOT ALLOW THE EXCLUSION OF CERTAIN WARRANTIES. THEREFORE, SOME OF THE ABOVE LIMITATIONS ON WARRANTIES IN THIS SECTION MAY NOT APPLY TO YOU.

INDEMNIFICATION

You agree to defend, indemnify, and hold us and our officers, directors, employees, successors, licensees, subcontractors, agents and assigns harmless from and against any and all losses, claims, costs, expenses, damages, actions, or demands, including, without limitation, reasonable legal and accounting fees, arising or resulting from: (i) your violation of these Terms of Use; (ii) your misuse of the Sites and/or the Content, and (iii) your violation of any intellectual property or other right of any third party.

TERMINATION OF THESE TERMS OF USE

IBSA reserves the right, in its sole discretion, to terminate your access to the Sites and the related services or any portion thereof at any time, without notice.

UPDATES TO THE SITE AND THESE TERMS OF USE

We reserve the right at any time to without notice modify or discontinue, temporarily or permanently, this or any web site or any portion thereof. IBSA may also, at any time, revise these Terms of Use. Any such changes to the Terms of Use will be posted on this page, and we will update the "Updated and Effective"; date to reflect the date of the changes. By continuing to use this or any IBSA Sites after the posting of such changes, you are bound by any such revisions and should therefore periodically visit this page to review the then current Terms of Use.

AVAILABILITY OF THE SITE

Access to the Sites is permitted at IBSA’s discretion. IBSA reserves the right to withdraw, amend, or restrict the services we provide on this Sites without notice.

COMPLIANCE WITH APPLICABLE LAWS

The Sites are intended to be used only by residents of the United States. We make no claims concerning whether any Content may be downloaded, viewed, or be appropriate for use outside of the United States. If you access the Sites from outside of the United States, you do so at your own risk. Whether inside or outside of the United States, you are solely responsible for ensuring compliance with the laws of your specific jurisdiction.

DIGITAL MILLENNIUM COPYRIGHT ACT

The Sites may make chat rooms, forums, Listservs and message boards available to its users. By accessing and using any such features, or by in any other manner sending information to IBSA, you represent that you are solely responsible for all the content, including, but not limited to text, photographs, caricatures, illustrations, designs, icons, articles, audio clips, and video clips (collectively, “User Content”) that you post, e-mail, or otherwise transmit via the Sites. You represent by posting that your User Content complies with all applicable laws and regulations, including, but not limited to, the Digital Millennium Copyright Act. IBSA, IBSA does not control User Content posted or otherwise transmitted via the Sites and does not guarantee the accuracy, integrity, or quality of such User Content. Any communications you send to the Sites or otherwise to us by electronic mail, with the exception of Personally Identifiable Information as defined in the IBSA Privacy Policy, shall be deemed to be non-confidential and we shall have no obligation of any kind with respect to such information and shall be free to reproduce, use, disclose, and distribute the information to others without limitation. We shall be free to use any ideas, concepts, know-how or techniques contained in such information for any purpose whatsoever, including, but not limited to, developing, manufacturing and marketing products incorporating such information.

You will indemnify and hold harmless us, our affiliates, and each of our and their respective directors, officers, managers, employees, shareholders, agents, representatives and licensors, from and against any liability of any nature arising out of related to any content or materials displayed on or submitted via the Sites by you or by others using your username and password. You also grant us a royalty-free, perpetual, irremovable, non-exclusive, unrestricted, worldwide license to use, copy, modify, transmit, sell, exploit, create derivative works from, or distribute in any manner or medium the materials you post or submit via such features. The foregoing grant includes the right to exploit any proprietary rights in such posting or submission, including, but not limited to, rights under copyright, trademark or patent laws that exist in any relevant jurisdiction.

Our designated agent under the Digital Millennium Copyright Act (the “Act”) for the receipt of any Notification of Claimed Infringement which may be given under that Act is as follows:
IBSA Pharma Inc.
Attention: DMCA
8 Campus Drive Suite 201
Parsippany, NJ 07054

If you believe that your work has been copied on the Site(s) in a way that constitutes copyright infringement, please provide our agent with notice in accordance with the requirements of the Act, including (i) a description of the copyrighted work that has been infringed and the specific location on the Site(s) where such work is located; (ii) a description of the location of the original or an authorized copy of the copyrighted work; (iii) your address, telephone number and e-mail address; (iv) a statement by you that you have a good faith belief that the disputed use is not authorized by the copyright owner, its agent or the law; (v) a statement by you, made under penalty of perjury, that the information in your notice is accurate and that you are the copyright owner or authorized to act on the copyright owner’s behalf; and (vi) an electronic or physical signature of the owner of the copyright or the person authorized to act on behalf of the owner of the copyright interest.

FORWARD-LOOKING STATEMENTS

The information included in (or accessible from) this or the Sites may contain forward-looking statements that involve risks and uncertainties, including statements with respect to the safety, efficacy, potential benefits, and successful development of IBSA’s products under development. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are: the submission, acceptance, and approval of regulatory filings; the results of clinical trials with respect to products under development; the scope of IBSA’s patent protection with respect to such product candidates; the commercial success of IBSA’s products; the ability of the company to attract and retain qualified personnel; the performance of IBSA’s licensees; the availability of sufficient funds to continue research and development efforts; and certain other factors that may affect future operating results and are detailed in any periodic reports filed with the Securities and Exchange Commission.

GOVERNING LAW

To the maximum extent permitted by law, these Terms of Use is governed by the laws of the State of New Jersey, U.S.A. and you hereby consent to the exclusive jurisdiction and venue of courts in Morris County, New Jersey, U.S.A., without regard to its conflicts of laws principles, in all disputes arising out of or relating to the use of the Sites. Use of the Sites is unauthorized in any jurisdiction that does not give effect to all provisions of these Terms of Use, including without limitation this paragraph.

You agree that no joint venture, partnership, employment, or agency relationship exists between you and IBSA as a result of these Terms of Use or use of the Sites.

VOID WHERE PROHIBITED

The Sites and their content are intended to comply with the laws and regulations in the U.S. Although the information on this Web site is accessible to users outside of the U.S., the information pertaining to IBSA products is intended for use only by residents of the U.S. Other countries may have laws, regulatory requirements and medical practices that differ from those in the U.S. The Sites links to other sites produced by IBSA’s various operating divisions and subsidiaries, some of which are outside the U.S. Those sites may have information that is appropriate only to that particular originating country. IBSA reserves the right to limit provision of its products or services to any person, geographic region or jurisdiction and/or to limit the quantities or any products or services we provide. Any offer for any product or service made on the Sites is void where prohibited.

RIGHT TO ALTER OR REMOVE CONTENT. RIGHT TO SUSPEND ACCOUNTS

IBSA reserves the right to alter or delete materials from this or any IBSA Site at any time at its sole discretion. IBSA reserves the right to remove any abusive, illegal, or incorrect user postings or third-party content from this or any Sites at any time at its sole discretion. IBSA reserves the right to suspend or terminate any and all accounts you have created on an IBSA Site for your violation of any laws, regulations, or the Terms of Use.

If you violate any part of these Terms of Use, your permission to access and/or use the Content and the services automatically terminates and you must immediately destroy any copies you have made of the Content.

MISCELLANEOUS

If any provision of these Terms of Use is held to be unlawful, void or unenforceable, then such provision shall be severable without affecting the enforceability of all remaining provisions.

A printed version of these Terms of Use and of any notice given in electronic form shall be admissible in judicial or administrative proceedings based upon or relating to these Terms of Use to the same extent and subject to the same conditions as other business documents and records originally generated and maintained in printed form.

© 2018 IBSA Pharma Inc.

Use

TIROSINT® (levothyroxine sodium) capsules, is a prescription medicine that contains a hormone called levothyroxine which is normally produced in your body by the thyroid gland. It is meant to replace the hormone to treat a condition called hypothyroidism. TIROSINT is not for use in people with temporary hypothyroidism caused by thyroiditis, or inflammation of the thyroid gland.

Tirosint Important Product Information

IMPORTANT SAFETY INFORMATION for TIROSINT (levothyroxine sodium) CAPSULES

NOT FOR TREATMENT OF OBESITY OR FOR WEIGHT LOSS

Thyroid hormones, including TIROSINT, either alone or with other therapeutic agents, should not be used for the treatment of obesity or for weight loss.

In euthyroid patients, doses within the range of daily hormonal requirements are ineffective for weight reduction.

Larger doses may produce serious or even life threatening manifestations of toxicity, particularly when given in association with sympathomimetic amines such as those used for their anorectic effects.

What is the most important information you should know about TIROSINT?
TIROSINT® (levothyroxine sodium) is a prescription medicine that contains a hormone called levothyroxine which is normally produced in your body by the thyroid gland. It is used to treat adults and children 6 years of age and older:

  • To replace or give extra levothyroxine in people whose thyroid gland does not naturally produce enough (a condition called hypothyroidism).
  • Who need surgery and radioiodine therapy to manage a type of thyroid cancer called thyroid-dependent well-differentiated thyroid cancer.

Do not use TIROSINT to treat weight problems or for weight loss. Do not take more TIROSINT than your doctor prescribes. Over dosage or taking too much TIROSINT may cause life-threatening side effects or death.

TIROSINT should not be used by children less than 6 years of age or who cannot swallow an intact capsule. TIROSINT is also not for use in people with temporary hypothyroidism caused by thyroiditis, or inflammation of the thyroid gland.

Do not take TIROSINT if your adrenal glands are not working well and you have not been treated with glucocorticoid replacement for this problem. Before you take TIROSINT, tell your healthcare provider about all your medical conditions, including if you: Currently have or have previously had heart problems; currently have or have previously had thyroid nodules; have kidney or pituitary gland problems; have any food or drug allergies; have a low red blood cell count; have diabetes; have weak or weakening bones (osteoporosis); currently have or have previously had a history of blood clotting problems. Also tell your healthcare provider if you are: Pregnant or planning to become pregnant, or are breastfeeding. TIROSINT may harm your unborn baby. Your doctor may need to change your TIROSINT dose while you are pregnant. TIROSINT passes into breast milk. Talk to your doctor about the best way to feed your baby if you take TIROSINT.

It is important that you tell your doctor about all the medicines you take including prescription and over-the-counter medicines, vitamins, and herbal supplements. TIROSINT may affect the way other medicines work, and other medicines may affect how TIROSINT works. Ask your doctor or pharmacist for a list of medicines that may interact with TIROSINT. Certain foods such as soybean flour, cottonseed meal, walnuts, dietary fiber, and grapefruits or grapefruit juice may affect the way that your body absorbs TIROSINT. Tell your healthcare provider if you regularly eat these foods, as they may require your dose of TIROSINT to be adjusted.

Important information about taking TIROSINT: You should take TIROSINT exactly as your doctor tells you to take it. Your doctor will tell you how much TIROSINT to take each day. You should not stop taking TIROSINT or change your dose unless your doctor tells you to. Take TIROSINT once each day, on an empty stomach, approximately 30 minutes to 1 hour before breakfast. Certain medicines can interfere with how TIROSINT is absorbed by your body. Take TIROSINT: At least 4 hours before or after you take medicines that contain calcium carbonate or iron (ferrous sulfate); and at least 4 hours before you take medicines that contain bile acid sequestrants or ion exchange resins. Ask your doctor if you are not sure whether any medicines you are taking may contain these ingredients. Your doctor should do certain blood tests while you are taking TIROSINT and may change your daily dose of TIROSINT as needed.

What are the possible side effects of TIROSINT? The most common side effects of TIROSINT include irregular heartbeat, chest pain, shortness of breath, leg cramps, headache, nervousness, irritability, sleep problems (insomnia), tremors, muscle weakness, change in appetite, weight loss, vomiting, diarrhea, sweating a lot, heat intolerance, fever, changes in menstrual period, and hives or skin rash. TIROSINT may cause serious side effects, including heart problems. Your risk for these problems may be greater if you are elderly, have heart problems, or if you take too much TIROSINT. Tell your doctor right away if you develop heart problems, as your doctor may choose to reduce your dose or stop treatment with TIROSINT. TIROSINT may also cause worsening of blood sugar control in diabetic patients and weak or brittle bones. Tell your doctor if you are diabetic or if you already have weak or brittle bones (osteoporosis) before taking TIROSINT. Partial hair loss may occur during the first months of treatment with TIROSINT. This is usually temporary and lasts a short period of time.

USE ONLY AS DIRECTED BY YOUR HEALTHCARE PROFESSIONAL. These are not all the possible side effects of TIROSINT. Talk to your healthcare provider or pharmacist for more information or for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or by visiting www.fda.gov/medwatch. For more dosing information, please see the accompanying full Prescribing Information and Patient Information.

IBSA Pharma Inc.
(USA) 49962