END USER LICENSE AND TERMS OF SERVICE
Effective Date: August 26, 2020
Last Updated Date: August 26, 2020
- Acceptance of the Terms and Conditions.
- Binding Agreement; Description. Mylan Specialty L.P., a Viatris Company (“Viatris,” “we,” “us” or “our”) provides and makes available its PODMANAGER® mobile application (together with all updates made thereto, the “App”) subject to the terms and conditions contained in this End User License and Terms of Service (this “EULA”). Please read this EULA carefully. By accessing, downloading, installing or otherwise using the App, you acknowledge that you have read, understood and agree to be bound by this EULA. If you do not accept this EULA’s terms and conditions, then you may not access, download, install or use the App.
AS FURTHER DESCRIBED BELOW, THIS EULA REQUIRES THE USE OF ARBITRATION ON AN INDIVIDUAL BASIS TO RESOLVE MOST DISPUTES ARISING OUT OF YOUR USE OF THE APP, RATHER THAN JURY TRIALS OR CLASS ACTIONS, AND ALSO LIMITS THE REMEDIES AVAILABLE TO YOU IN THE EVENT OF A DISPUTE.
The App Does Not Provide Medical Advice. We make the App available for use by any patients taking any medication, including but not limited to the TOBI® PODHALER® (Tobramycin Inhalation Powder) (the “Medication”). Before using the Medication, you should consult with a licensed medical professional if you have any questions regarding your medical condition or use of the Medication or any other medicines you take. WITHOUT LIMITATION OF ANY OTHER TERMS IN THIS EULA, WE DO NOT MAKE ANY REPRESENTATIONS OR WARRANTIES THAT THE APP IS INTENDED TO AND/OR DOES DIAGNOSE, TREAT, CURE OR PREVENT ANY MEDICAL DISORDERS OR CONDITIONS, AND YOU HEREBY ACKNOWLEDGE THIS DISCLAIMER AND THAT WE ARE NOT ENGAGED IN PROVIDING YOU WITH MEDICAL ADVICE AND/OR HEALTHCARE SERVICES BY PROVIDING YOU WITH ACCESS TO THE APP. We are not responsible in any way for any health problems or injuries, including, without limitation, incapacity or death, which may result from or be related to your use of, or inability to use, the App. - Changes to this EULA. You understand and agree that Viatris may change this EULA at any time without prior notice; but Viatris will endeavor to provide you with prior notice of any material changes. You may read a current, effective copy of this EULA at any time by selecting the appropriate link on the App. Revised terms and conditions will become effective at the time of posting to the App. Any use of the App after such date will constitute your acceptance of such revised terms and conditions. If any change to this EULA is not acceptable to you, then your sole remedy is to stop accessing and otherwise using, and to delete and uninstall, the App. Notwithstanding the preceding sentences, no revisions to this EULA will apply to any dispute between you and Viatris that arose prior to the effective date of such revision.
- Consideration. You understand and agree that this EULA is entered into in consideration of your use of the App and other good and valuable consideration, the receipt and sufficiency of which are hereby acknowledged. You acknowledge that Viatris may rely on your acceptance of the terms of this EULA as a condition of providing you with access and use of the App.
- Privacy Policy. Your access to and use of the App is also subject to the App Privacy Policy located at (“App Privacy Policy”), the terms and conditions of which are incorporated herein by reference.
- Eligibility. THE APP IS NOT FOR PERSONS UNDER THE AGE OF 13 OR FOR ANY USERS PREVIOUSLY SUSPENDED OR REMOVED BY VIATRIS FROM THE APP OR ANY OTHER MOBILE APPLICATION OFFERED BY VIATRIS OR ITS AFFILIATES. IF YOU ARE UNDER 13 YEARS OF AGE, YOU MUST NOT USE OR ACCESS THE APP AT ANY TIME OR IN ANY MANNER. Furthermore, by using the App, you affirm that you are at least 13 years of age.
- Binding Agreement; Description. Mylan Specialty L.P., a Viatris Company (“Viatris,” “we,” “us” or “our”) provides and makes available its PODMANAGER® mobile application (together with all updates made thereto, the “App”) subject to the terms and conditions contained in this End User License and Terms of Service (this “EULA”). Please read this EULA carefully. By accessing, downloading, installing or otherwise using the App, you acknowledge that you have read, understood and agree to be bound by this EULA. If you do not accept this EULA’s terms and conditions, then you may not access, download, install or use the App.
- The App.
- Description. The App allows end users to view, upload, store and manage information about their use of the Medication (or other medications), including treatment schedule and reminders, drug and safety information for the Medication, and other relevant information about the Medication. The App will also include patient support information for patients who have been prescribed the Medication.
- Your Information. You may be required to provide certain information as a condition of downloading, installing or using the App or certain of its features. All information collected through or in connection with the App is subject to the App Privacy Policy.
- Mobile Services. The App is intended to be accessible via a mobile phone, tablet or other wireless device (collectively, “Mobile Services”). You acknowledge and agree that all mobile device system requirements necessary to use the App are your own responsibility. Your mobile carrier’s normal messaging, data and other rates and fees will apply to your use of the Mobile Services. You are solely responsible for checking with your mobile carrier to determine if the Mobile Services are available for your mobile device(s), what restrictions, if any, may be applicable to your use of the Mobile Services, and how much they will cost you. Nevertheless, all use of the App and the Mobile Services must be in accordance with this EULA.
- Unauthorized Use. Viatris is not responsible for the security of your mobile device or any unauthorized access or use of the App on your device or of your account.
- Changes to the App. Viatris may, in its discretion, offer updates to the App. These updates may expand, diminish or change the features or functionality of the App. Viatris grants you a personal, limited, non-exclusive, revocable, non-transferable, non-assignable license to download updates to the App that may be made available by Viatris to update or restore the App on your personal mobile device, subject to the terms and conditions of this EULA applicable to the App, and subject to any additional terms that may accompany such update. Updates may be made available to you through the App, and may allow you to choose whether or not to install the update. If you do not install an update, the functionality of the App could be compromised.
- Intellectual Property Rights
- License. The App is licensed, not sold, to you solely for your personal, non-commercial use under the terms of this EULA. Viatris reserves all rights not expressly granted to you. Subject to your complete and ongoing compliance with this EULA, Viatris hereby grants you a personal, limited, non-exclusive, revocable, non-transferable, non-assignable license (without right to sublicense) to download and install the App on your mobile device and use the App on your mobile device solely for your personal, non-commercial use.
- Content. The content made available to you on or through the App, including without limitation, any text, graphics, photos, software or interactive features, may be protected by copyright or other intellectual property rights and owned by or licensed to Viatris or its affiliates or Viatris’ third party licensors (the “Viatris Content”). You may download and print material from the app for your personal, non-commercial use, but you may not copy, reproduce, modify, upload, republish, transmit, post or distribute any materials from the App for any other use or for any other reason without prior express written permission of Viatris or the intellectual property owner of such material or as otherwise specified in this EULA or permitted by the App’s functionalities. You may not modify or use any materials obtained from or available through the App unless you have obtained the prior express written authorization of Viatris or the applicable intellectual property owner. Viatris or its affiliates solely own all design rights, databases and compilation and other intellectual property rights in and to the App, in each case whether registered or unregistered, and any related goodwill.
- Marks. The Viatris trademarks, service marks and logos (the “Viatris Trademarks”) used or displayed on the App are the registered and unregistered trademarks or service marks owned by or licensed for use by Viatris or its affiliates. Other product and service names located on the App may be trademarks or service marks owned by third parties (the “Third-Party Trademarks,” and, collectively with the Viatris Trademarks, the “Trademarks”). Nothing on the App or in this EULA should be construed as granting, by implication, estoppel or otherwise, any license or right to use any Trademark displayed on the App without Viatris’ prior express written consent for each individual use. You may not use the Trademarks to disparage Viatris or the applicable third party, Viatris’ or a third party’s products or services, or in any manner (using commercially reasonable judgment) that may damage any goodwill in the Trademarks. You may not use any Trademarks as part of a link to or from any website without Viatris’ prior express written consent. All goodwill generated from the use of any Viatris Trademark will inure solely to Viatris’ benefit.
- Restrictions. You may not sell, rent, lend, transfer, assign, license, sublicense or modify the Viatris Content or App, and you may not reproduce, display, publicly perform, adapt, translate, make a derivative version of, distribute or otherwise use the Viatris Content or App in any way for any public or commercial purpose. You also may not attempt to decompile, reverse engineer, derive the source code of, modify or create derivative works of the App (including any updates) or any part thereof (except as and only to the extent any of the foregoing restrictions are prohibited by applicable law) or otherwise use the App in any manner that is not expressly authorized by this EULA. Without limiting the foregoing restrictions, you also may not: (a) take any action that imposes an unreasonable load on the App’s infrastructure; (b) use any device, software or routine to interfere or attempt to interfere with the proper working of the App, or any activity conducted on the App; (c) transmit or otherwise make available any virus, worm, spyware or any other computer code, file or program that may or is intended to disable, overburden, impair, damage or hijack the operation of any hardware, software or telecommunications equipment, or any other aspect of the App or communications equipment and computers connected to the App; (d) use the App in violation of any applicable local, state, federal, national or provincial laws, statutes, regulations, rules or orders; (e) remove, delete, alter or obscure any Trademarks or any intellectual property or proprietary rights notices from the App; (f) frame or link to any of the materials or information available on the App; or (g) harass, abuse or harm Viatris employees or any third party. If you violate any part of this EULA (including, without limitation, any of the foregoing restrictions), then your right to access and/or use the Viatris Content and App will automatically terminate and you must immediately destroy any copies you have made of the Viatris Content and uninstall and delete the App.
- Feedback.We appreciate hearing from our users and welcome your comments regarding the App. Please be advised, however, that if you send us any ideas for products, services, features, modifications, enhancements, content, refinements, technologies, content offerings (such as audio, visual, games or other types of content), promotions, strategies or product/feature names, or any related documentation, artwork, computer code, diagrams or other materials (collectively “Feedback”), then regardless of what your accompanying communication may say, the following terms will apply: (a) Viatris has no obligation to review, consider or implement your Feedback, or to return to you all or part of any Feedback for any reason; (b) Feedback is provided on a non-confidential basis, and Viatris is not under any obligation to keep any Feedback you send confidential or to refrain from using or disclosing it in any way; and (c) you irrevocably grant Viatris perpetual and unlimited permission to disclose, reproduce, distribute, license, sublicense, transfer, create derivative works of, modify, publicly perform (including on a through-to-the-audience basis), communicate to the public, make available, publicly display and otherwise use and exploit the Feedback and derivatives thereof for any purpose and without restriction, free of charge and without attribution of any kind.
- Dispute Resolution.
- Mandatory Arbitration. Please read this carefully. It affects your rights. YOU, AND ANY OTHER PARTIES ON WHOSE BEHALF YOU ARE ACCESSING THE APP, AND YOUR AND THEIR RESPECTIVE SUCCESSORS AND ASSIGNS, AND VIATRIS, ITS CORPORATE PARENTS, SUBSIDIARIES, AFFILIATES, PREDECESSORS IN INTEREST, AND ITS AND THEIR RESPECTIVE SUCCESSORS AND ASSIGNS (COLLECTIVELY, THE “VIATRIS PARTIES”), AGREE TO ARBITRATION AS DESCRIBED HEREIN (EXCEPT FOR MATTERS THAT MAY BE TAKEN TO SMALL CLAIMS COURT AND AS OTHERWISE PROVIDED FOR BELOW) AS THE EXCLUSIVE FORM OF DISPUTE RESOLUTION FOR ALL DISPUTES AND CLAIMS ARISING OUT OF OR RELATING TO THIS EULA OR THE APP.
- Commencing Arbitration. A party who intends to seek arbitration must first send to the other, by a reputable courier with a tracking mechanism, a written notice of intent to arbitrate (a “Notice”), or, in the absence of a mailing address provided by you to Viatris, to you via any other method available to Viatris, including via e-mail. The Notice to Viatris should be addressed to 1000 Mylan Boulevard, Canonsburg, PA 15317, Attn: Lead Legal Counsel, Viatris (the “Arbitration Notice Address”). The Notice must: (a) describe the nature and basis of the claim or dispute; and (b) set forth the specific relief sought (the “Demand”). If you and Viatris do not reach an agreement to resolve the claim within thirty (30) days after the Notice is received, then you or Viatris may commence an arbitration proceeding as set forth below or file a claim in small claims court, if your claim qualifies. THE ARBITRATION WILL BE ADMINISTERED BY THE AMERICAN ARBITRATION ASSOCIATION (“AAA”) IN ACCORDANCE WITH ITS COMMERCIAL ARBITRATION RULES AND THE SUPPLEMENTARY PROCEDURES FOR CONSUMER RELATED DISPUTES (THE “Rules”), AS MODIFIED BY THIS EULA. There is no judge or jury in arbitration, and court review of an arbitration award is limited. However, an arbitrator can award on an individual basis the same damages and relief as a court (including injunctive and declaratory relief or statutory damages), and must follow the terms of THIS EULA as a court would. The Rules and AAA forms are available at http://www.adr.org. If you are required to pay a filing fee to commence arbitration against Viatris, then Viatris will promptly reimburse you for your confirmed payment of the filing fee upon Viatris’ receipt of Notice at the Arbitration Notice Address that you have commenced arbitration along with a receipt evidencing payment of the filing fee, unless your Demand is equal to or greater than $1,000 or was filed in bad faith or was frivolous, in which case you are solely responsible for the payment of the filing fee, and we may seek a refund of the filing fee from you in arbitration proceedings if we have previously reimbursed you for such filing fee.
- Arbitration Proceeding. The arbitration will be conducted in English. A single independent and impartial arbitrator with his or her primary place of business in the Commonwealth of Pennsylvania will be appointed pursuant to the Rules, as modified herein. The arbitrator shall have the power to rule on the arbitrability of the dispute or claim, any challenge to its jurisdiction and to the validity or enforceability of any portion of this Dispute Resolution section. You and Viatris agree to the following rules, which are intended to streamline the dispute resolution process and reduce the costs and burdens on the parties: (a) the arbitration will be conducted online and/or be solely based on written submissions, the specific manner to be chosen by the party initiating the arbitration; (b) the arbitration will not require any personal appearance by the parties or witnesses unless otherwise mutually agreed in writing by the parties; and (c) any judgment on the award rendered by the arbitrator may be entered in any court of competent jurisdiction.
- No Class Actions. YOU AND VIATRIS AGREE THAT YOU AND VIATRIS MAY BRING CLAIMS AGAINST THE OTHER ONLY IN YOUR OR ITS INDIVIDUAL CAPACITY AND NOT AS A PLAINTIFF OR CLASS MEMBER IN ANY PURPORTED CLASS OR REPRESENTATIVE PROCEEDING. FURTHER, YOU AGREE THAT THE ARBITRATOR MAY NOT CONSOLIDATE PROCEEDINGS OF MORE THAN ONE PERSON’S CLAIMS, AND MAY NOT OTHERWISE PRESIDE OVER ANY FORM OF A REPRESENTATIVE OR CLASS PROCEEDING, AND THAT IF THIS SPECIFIC PROVISO IS FOUND TO BE UNENFORCEABLE, THEN THE ENTIRETY OF THIS MANDATORY ARBITRATION SECTION WILL BE NULL AND VOID.
- Decision of the Arbitrator. Barring extraordinary circumstances, the arbitrator will issue his or her decision within one hundred twenty (120) days from the date the arbitrator is appointed. The arbitrator may extend this time limit for an additional thirty (30) days in the interests of justice. All arbitration proceedings will be closed to the public and confidential, and all records relating thereto will be permanently sealed, except as necessary to obtain court confirmation of the arbitration award. The award of the arbitrator will be in writing and will include a statement setting forth the reasons for the disposition of any claim. The arbitrator will apply the laws of the Commonwealth of Pennsylvania in conducting the arbitration. You acknowledge that this EULA and your use of the App evidences a transaction involving interstate commerce. The United States Federal Arbitration Act will govern the interpretation, enforcement and proceedings pursuant to the Mandatory Arbitration clause in this EULA.
- Equitable Relief. The foregoing provisions of this Dispute Resolution section do not apply to any claim in which either party seeks equitable relief to protect such party’s copyrights, trademarks or patents. You acknowledge that, in the event Viatris breaches this EULA, the damage or harm, if any, caused to you will not entitle you to seek injunctive or other equitable relief against Viatris, and your only remedy will be for monetary damages, subject to the limitations of liability set forth in this EULA.
- Claims. You and Viatris agree that, notwithstanding any other rights either such party may have under law or equity, any cause of action arising out of or related to this EULA or the App, excluding a claim for indemnification, must commence within one year after the cause of action accrues. Otherwise, such cause of action is permanently barred.
- Improperly Filed Claims. All claims that you bring against Viatris or that Viatris brings against you must be resolved in accordance with this Dispute Resolution section. All claims filed or brought contrary to this Dispute Resolution section will be considered improperly filed. Should either party file a claim contrary to this Dispute Resolution section or any claim that is found to be frivolous or made in bad faith, the other party may recover attorneys’ fees and costs in arbitration up to $5,000, provided that the other party has notified the claiming party in writing of the improperly filed claim, and such claim has not been promptly withdrawn.
- Modifications. In the event that Viatris makes any future change to the Mandatory Arbitration provision (other than a change to Viatris’ Arbitration Notice Address), you may reject any such change by sending us written notice within thirty (30) days of the change to Viatris’ Arbitration Notice Address, in which case your account with Viatris and your license to use the App will terminate immediately, and this Dispute Resolution provision, as in effect immediately prior to the changes you reject, will survive the termination of this EULA.
- Enforceability. If only Section 5.a.iii or the entirety of this Section 5 is found to be unenforceable, then the entirety of this Section 5 will be null and void and, in such case, the parties agree that the exclusive jurisdiction and venue described in Section 11 will govern any action arising out of or related to this EULA, provided that if for any reason a claim proceeds in court rather than in arbitration we each waive any right to a jury trial.
- Mandatory Arbitration. Please read this carefully. It affects your rights. YOU, AND ANY OTHER PARTIES ON WHOSE BEHALF YOU ARE ACCESSING THE APP, AND YOUR AND THEIR RESPECTIVE SUCCESSORS AND ASSIGNS, AND VIATRIS, ITS CORPORATE PARENTS, SUBSIDIARIES, AFFILIATES, PREDECESSORS IN INTEREST, AND ITS AND THEIR RESPECTIVE SUCCESSORS AND ASSIGNS (COLLECTIVELY, THE “VIATRIS PARTIES”), AGREE TO ARBITRATION AS DESCRIBED HEREIN (EXCEPT FOR MATTERS THAT MAY BE TAKEN TO SMALL CLAIMS COURT AND AS OTHERWISE PROVIDED FOR BELOW) AS THE EXCLUSIVE FORM OF DISPUTE RESOLUTION FOR ALL DISPUTES AND CLAIMS ARISING OUT OF OR RELATING TO THIS EULA OR THE APP.
- Limitation of Liability and Disclaimer of Warranties.
- VIATRIS, ITS AFFILIATES AND THEIR RESPECTIVE OFFICERS, DIRECTORS, EMPLOYEES, AGENTS, SUPPLIERS AND LICENSORS (COLLECTIVELY, THE “VIATRIS PARTIES”) MAKE NO WARRANTIES OR REPRESENTATIONS ABOUT THE APP AND ANY VIATRIS CONTENT OR OTHER CONTENT AVAILABLE ON THE APP, INCLUDING BUT NOT LIMITED TO THE ACCURACY, RELIABILITY, COMPLETENESS, AVAILABILITY, TIMELINESS OR RELIABILITY THEREOF. THE VIATRIS PARTIES WILL NOT BE SUBJECT TO LIABILITY FOR THE TRUTH, ACCURACY OR COMPLETENESS OF ANY CONTENT OR ANY OTHER INFORMATION CONVEYED TO YOU OR ANY OTHER USER, OR FOR ERRORS, MISTAKES OR OMISSIONS THEREIN, OR FOR ANY DELAYS OR INTERRUPTIONS OF THE DATA OR INFORMATION STREAM FROM WHATEVER CAUSE. AS A USER, YOU AGREE THAT YOU USE THE APP AND ANY CONTENT AT YOUR OWN RISK. FURTHERMORE, YOU ACKNOWLEDGE AND AGREE THAT NEITHER THIS EULA NOR YOUR USE OF THE APP SHALL CREATE ANY STATUTORY, IMPLIED OR OTHER WARRANTIES WITH RESPECT TO YOUR USE OF THE MEDICATION.
- THE VIATRIS PARTIES DO NOT WARRANT THAT THE APP WILL BE COMPATIBLE WITH ANY SOFTWARE, APPLICATIONS, SYSTEMS OR SERVICES, WILL OPERATE WITHOUT INTERUPTION, WILL BE SECURE, WILL PROVIDE TIMELY OR ACCURATE INFORMATION, WILL MEET ANY PERFORMANCE OR RELIABILITY STANDARDS, WILL OPERATE ERROR FREE, OR THAT THE APP AND ANY CONTENT ARE FREE OF COMPUTER VIRUSES OR SIMILAR CONTAMINATION OR DESTRUCTIVE FEATURES. IF YOUR USE OF THE APP OR ANY CONTENT RESULTS IN THE NEED FOR SERVICING OR REPLACING EQUIPMENT OR DATA, NO VIATRIS PARTY WILL BE RESPONSIBLE FOR THOSE COSTS.
- THE APP AND ALL CONTENT ARE PROVIDED ON AN “AS IS” AND “AS AVAILABLE” BASIS WITHOUT ANY WARRANTIES OF ANY KIND, WHETHER EXPRESS, IMPLIED OR STATUTORY. THE VIATRIS PARTIES DISCLAIM ALL WARRANTIES, INCLUDING BUT NOT LIMITED TO THE WARRANTIES OF TITLE, MERCHANTABILITY, NON-INFRINGEMENT OF THIRD PARTIES’ RIGHTS AND FITNESS FOR PARTICULAR PURPOSE.
- IN NO EVENT WILL ANY VIATRIS PARTY BE LIABLE FOR ANY SPECIAL, INDIRECT, PUNITIVE, INCIDENTAL OR CONSEQUENTIAL DAMAGES, LOST PROFITS OR DAMAGES RESULTING FROM ANY INJURY OR DEATH, DATA, LOSS OF DATA OR BUSINESS INTERRUPTION RESULTING FROM OR IN CONNECTION WITH THE USE OR INABILITY TO USE THE APP OR ANY CONTENT, WHETHER BASED ON WARRANTY, CONTRACT, TORT (INCLUDING NEGLIGENCE) OR ANY OTHER LEGAL THEORY, EVEN IF THE VIATRIS PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES. WITHOUT LIMITING THE FOREGOING, VIATRIS’ LIABILITY, AND THE LIABILITY OF ANY OTHER VIATRIS PARTIES, TO YOU OR ANY THIRD PARTIES ARISING FROM THE APP IS LIMITED TO $100.
- SOME STATES DO NOT ALLOW EXCLUSION OF IMPLIED WARRANTIES OR LIMITATION OF LIABILITY FOR INCIDENTAL OR CONSEQUENTIAL DAMAGES, SO THE FOREGOING LIMITATIONS OR EXCLUSIONS MAY NOT APPLY TO YOU. IN SUCH STATES, THE LIABILITY OF THE VIATRIS PARTIES WILL BE LIMITED TO THE GREATEST EXTENT PERMITTED BY LAW.
- Third Party Disputes. VIATRIS IS NOT AFFILIATED WITH ANY THIRD PARTY RELATED TO YOUR USE OF THE APP, INCLUDING, WITHOUT LIMITATION, ANY LICENSED HEALTHCARE PROFESSIONAL OR MOBILE SERVICE CARRIER, AND ANY DISPUTE YOU HAVE WITH ANY SUCH THIRD PARTY IS DIRECTLY BETWEEN YOU AND SUCH THIRD PARTY, AND YOU IRREVOCABLY RELEASE THE VIATRIS PARTIES FROM ANY AND ALL CLAIMS, DEMANDS AND DAMAGES (ACTUAL AND CONSEQUENTIAL) OF EVERY KIND AND NATURE, KNOWN AND UNKNOWN, ARISING OUT OF OR IN ANY WAY CONNECTED WITH SUCH DISPUTES.
- Indemnification. You agree to defend, indemnify and hold harmless the Viatris Parties from and against any claims, actions or demands, including, without limitation, reasonable attorneys’ fees and legal costs, arising or resulting from your breach of this EULA or your access to, use or misuse of the Viatris Content or App. Viatris will provide notice to you of any such claim, suit or proceeding. Viatris reserves the right to assume the exclusive defense and control of any matter which is subject to indemnification under this section. In such case, you agree to cooperate with any reasonable requests assisting Viatris’ defense of such matter.
- Termination of the EULA and App. Viatris reserves the right, in its sole discretion, to restrict, suspend or terminate your access to all or any part of the App, or to terminate this EULA, at any time and for any reason without prior notice or liability. Viatris reserves the right to change, suspend or discontinue all or any part of the App at any time without prior notice or liability. You may cease use of the App and terminate this EULA at any time and for any reason by uninstalling and deleting the App. You agree to cease all use of the App and uninstall and delete it upon termination of the EULA. Sections 3 through 13 will survive any termination of this EULA indefinitely.
- Consent to Electronic Communications. By using the App, you consent to receiving certain electronic communications from us, you may from time to time be asked to opt in to receiving other electronic communications from us, and you may opt-out of certain of these communications as described in the App Privacy Policy and in those communications themselves. You agree that any notices, agreements, disclosures or other communications that we send to you electronically will satisfy any legal communication requirements, including that such communications be in writing.
- Miscellaneous. This EULA is governed by the internal substantive laws of the Commonwealth of Pennsylvania without respect to its conflict of laws principles. If Section 5.a.iii or all of Section 5 is found to be unenforceable by a court of competent jurisdiction, then you expressly agree to submit to the exclusive personal jurisdiction of the state and federal courts sitting in Allegheny County, Pennsylvania. You agree that no joint venture, partnership, employment or agency relationship exists between you and Viatris as a result of this EULA or use of the App. If any provision of this EULA is found to be invalid by any court having competent jurisdiction, then the invalidity of such provision will not affect the validity of the remaining provisions of this EULA, which will remain in full force and effect. Viatris’ failure to enforce any provision of this EULA will not be construed as a waiver of that or any other provision herein. No waiver will be effective against Viatris unless made in writing, and no such waiver will be construed as a waiver in any other or subsequent instance. This EULA and the App Privacy Policy constitute the entire agreement between you and Viatris with respect to the subject matter hereof, and supersedes all previous or contemporaneous agreements, whether written or oral, between the parties with respect to the subject matter herein. The section headings are provided merely for convenience and will not be given any legal import. This EULA will inure to the benefit of our successors and assigns. You may not assign this EULA or any of the rights or licenses granted hereunder without the prior express written consent of Viatris. Viatris may assign this EULA, including all its rights hereunder, without restriction.
- Contact Us. If you would like to contact us in connection with your use of the App, then please contact us by mail at 1000 Mylan Boulevard, Canonsburg, PA 15317, or toll-free at 1-800-395-3376.
- NOTICE REGARDING GOOGLE (to Android users). You acknowledge that this EULA is between you and Viatris only and not with Google, and that Google is not responsible for the App or the content thereof. Google has no obligation whatsoever to furnish any maintenance and support services with respect to the App, nor to address any claims by you or any third party relating to the App or your possession and/or use of the App.
INDICATION
TOBI® PODHALER® (Tobramycin Inhalation Powder) 28 mg per capsule is indicated for the management of cystic fibrosis patients with Pseudomonas aeruginosa.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with forced expiratory volume in 1 second (FEV1) <25% or >80% predicted, or patients colonized with Burkholderia cepacia.
IMPORTANT SAFETY INFORMATION
TOBI PODHALER is contraindicated in patients with known hypersensitivity to any aminoglycoside.
Bronchospasm can occur with inhalation of TOBI PODHALER. Bronchospasm should be treated as medically appropriate.
Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected auditory, vestibular, renal, or neuromuscular dysfunction.
Ototoxicity, as measured by complaints of hearing loss or tinnitus, was reported by patients in the TOBI PODHALER clinical studies. Tinnitus may be a sentinel symptom of ototoxicity, and therefore the onset of this symptom warrants caution. Ototoxicity, manifested as both auditory and vestibular toxicity, has been reported with parenteral aminoglycosides. Vestibular toxicity may be manifested by vertigo, ataxia, or dizziness.
Cases of ototoxicity with aminoglycosides have been observed in patients with certain variants in the mitochondrially encoded 12S rRNA gene (MT-RNR1), particularly the m.1555A>G variant. Ototoxicity occurred in some patients even when their aminoglycoside serum levels were within the recommended range. Mitochondrial DNA variants are present in less than 1% of the general US population, and the proportion of the variant carriers who may develop ototoxicity as well as the severity of ototoxicity is unknown. In case of known maternal history of ototoxicity due to aminoglycoside use or a known mitochondrial DNA variant in the patient, consider alternative treatments other than aminoglycosides unless the increased risk of permanent hearing loss is outweighed by the severity of infection and lack of safe and effective alternative therapies.
Caution should be exercised when prescribing TOBI PODHALER to patients with known or suspected renal dysfunction. Nephrotoxicity was not observed during TOBI PODHALER clinical studies but has been associated with aminoglycosides as a class.
TOBI PODHALER should be used cautiously in patients with neuromuscular disorders, such as myasthenia gravis or Parkinson’s disease, since aminoglycosides may aggravate muscle weakness because of a potential curare-like effect on neuromuscular function.
Aminoglycosides can cause fetal harm when administered to a pregnant woman. Patients who use TOBI PODHALER during pregnancy, or who become pregnant while taking TOBI PODHALER, should be apprised of the potential hazard to the fetus. The amount of tobramycin excreted in human breast milk is unknown. However, systemic absorption of tobramycin following inhaled administration is expected to be minimal. A decision should be made whether to discontinue nursing or TOBI PODHALER. TOBI may cause intestinal flora alteration. Advise a woman to monitor the breastfed infant for loose or bloody stools and candidiasis.
Patients receiving concomitant TOBI and parenteral aminoglycoside therapy should be monitored as clinically appropriate for toxicities associated with aminoglycosides as a class. Serum tobramycin levels should be monitored.
Concurrent and/or sequential use of TOBI PODHALER with other drugs with neurotoxic, nephrotoxic, or ototoxic potential should be avoided. Some diuretics can enhance aminoglycoside toxicity by altering antibiotic concentrations in serum and tissue. TOBI PODHALER should not be administered concomitantly with ethacrynic acid, furosemide, urea, or mannitol.
In a clinical trial, the most commonly observed adverse events with TOBI PODHALER occurring at a frequency of at least 10%, were cough, lung disorder, productive cough, dyspnea, pyrexia, oropharyngeal pain, dysphonia, hemoptysis, and headache.
Please see Full Prescribing Information