LEADIANT BIOSCIENCES, INC. General Terms and Conditions of Use Agreement
Last updated: March 28, 2019
This Agreement applies to this Site and our online services. PLEASE READ THESE TERMS CAREFULLY. BY ACCESSING THE SITE, YOU AGREE TO BE BOUND BY THESE TERMS. IF YOU DO NOT WISH TO BE BOUND BY THESE TERMS, YOU MUST NOT ACCESS OR USE THIS SITE OR THE SERVICES. You agree to be bound by this Agreement, whether You are a “Visitor” (which means that You simply browse the Site) or a “Registered User” (which means that You have registered with the Site and established an account with LEADIANT (an “Account”)).
You also acknowledge and agree that we may modify this Agreement at any time, in our sole discretion, and that all modifications to this Agreement will be effective immediately upon our posting of the modifications on this Site. You agree that You will review this Agreement regularly, so that You are aware of and agree to any and all modifications made to this Agreement. If You object to any such changes, Your sole recourse will be to cease using the Site. Use of our Site after updates are posted and effective constitutes acceptance of any changes.
If You submit or otherwise provide information to LEADIANT, such information must be true, accurate, current, and complete, and You shall maintain and promptly update such information to keep it true, accurate, current and complete. The truth, accuracy, currency and completeness of such information is a condition to Your use of the Site and services. If we have reasonable grounds to suspect that such information is untrue, inaccurate, not current, or incomplete, we may suspend or terminate Your use of the Site (or any portion thereof).
- VISITORS. Visitors may browse the Site in accordance with this Agreement and will not have access to certain services without becoming a Registered User.
- REGISTERED USERS. Certain services are only available to Registered Users who are required to set up an Account prior to accessing such services. When You set up an Account, You are required to enter an email address and Password to access the services. You are solely responsible for maintaining the confidentiality of Your Account Information, and You are fully and solely responsible for all activities that occur under Your Password or Account identification. You must ensure that you exit from Your Account at the end of each session. You agree to notify us immediately of any unauthorized use of Your Account Information or any other breach of security. You are solely responsible for any and all use of Your account. Without limiting any rights which LEADIANT may otherwise have, LEADIANT reserves the right to take any and all action, as it deems necessary or reasonable, to ensure the security of the Site and Your Account, including, without limitation, terminating Your Account, changing Your Password, or requesting additional information to authorize transactions on Your Account. Notwithstanding the above, LEADIANT may rely on the authority of anyone accessing Your Account or using Your Password and in no event and under no circumstances shall LEADIANT be held liable to You for any liabilities or damages resulting from or arising out of (i) any action or inaction of LEADIANT under this provision, (ii) any compromise of the confidentiality of Your Account or Password, and (iii) any unauthorized access to Your Account or use of Your Password. You may not use anyone else’s Account at any time without the permission of the Account holder.
3. ACCESS RIGHTS.
We hereby grant to You a limited, non-exclusive, non-transferable license to access the Site and use the services solely for internal business purposes and personal use only as permitted under this Agreement (“Access Rights”). You understand and acknowledge that the Site and services are the property of LEADIANT, and You may not prepare derivative works of, modify, distribute, sell, lease, rent, sublicense, assign, export, or transfer in any other manner the services, the Site, or any underlying software, technology, or other information, including any printed materials of the same, unless expressly authorized hereunder. Any use of third party software provided in connection with the Site will be governed by such third parties’ licenses and not by this Agreement. You agree to be responsible for any act or omission of any users who access the Site under Your Account or using Your Password that, if undertaken by You, would be deemed a violation of this Agreement, and that such act or omission shall be deemed a violation of this Agreement by You.
We reserve the right, in our sole discretion, to deny use of the Site to anyone for any reason. You acknowledge and agree that we, in our sole discretion, at any time and with or without notice, may block or terminate your or any other party’s access to all or part of the Site, or change or discontinue any aspect or feature of the Site (including, without limitation, discontinuing the Site in its entirety); and that, without limitation of any other provisions of this Agreement, we reserve the right to take any actions at law or in equity that we deem appropriate in connection with the Site, services, and this Agreement.
4. YOUR RESPONSIBILITIES AND ACCEPTABLE USE OF THE SITE AND SERVICE.
Use of LEADIANT’s Site for any illegal purpose is strictly prohibited and a violation of these Terms.
You agree not to use the Site in any manner that: (a) violates any local, state, national, or international law; (b) threatens, stalks, harasses, abuses, defames, slanders, or in any other way harms another individual or business organization; (c) collects or stores personal data about other users without their consent, or otherwise prepares, compiles, uses, downloads, or copies any user information and/or usage information or any portion thereof, or transmits, provides or otherwise distributes (whether or not for a fee) such information to any third party; (d) impersonates any person or entity, misrepresents Your affiliation with a person or entity, or otherwise creates a false identity for the purpose of misleading others; (e) infringes someone else’s patent, trademark, trade secret, copyright or other intellectual property or other rights; (f) is vulgar, gratuitously violent, obscene, pornographic, indecent, lewd, libelous, invasive of another’s privacy, or racially, ethnically, or otherwise offensive, hateful, or abusive; (g) advocates or solicits violence, criminal conduct, or the violation of any local, state, national, or international law or the rights of any third party; (h) promotes sexually explicit or pornographic material or discrimination based on race, sex, religion, nationality, disability, sexual orientation, or age; (i) constitutes unsolicited or unauthorized advertising, junk or bulk email (spam), chain letters, or any other unsolicited commercial or non-commercial communication; or (h) transmits any material or communications that contain a petitions for signatures, chain letters, or letters relating to a pyramid scheme.
You may not interfere with or disrupt the Site, or servers or networks connected to the Site, interfere with or disrupt or inhibit others’ use of the Site, including through the upload or other transmission of any software viruses, worms, time bombs, corrupted files, Trojan horses or any other computer code, files, or programs that are designed or intended to disrupt, damage, overburden, impair, or limit the functioning of any software, hardware, network, server, or communications systems or equipment or use any robot, spider, or other such programmatic or automatic device, including but not limited to automated dial-in or inquiry devices, to obtain information from the Site or otherwise monitor or copy any portion of the Site. Further, you may not (a) use any LEADIANT domain name as a pseudonymous return email address; (b) attempt to disable, bypass, modify, defeat, or otherwise circumvent any security related tools incorporated into the Site; (c) change, modify, adapt, or otherwise alter the site, or change, modify, or alter another website so as to falsely imply that it is associated with this site; (d) inject content or code, or otherwise alter or interfere with the way any page from the site is rendered or displayed in another user’s browser or device; (e) reproduce, duplicate, copy, sell, or exploit for any commercial purposes, any portion of the Site or access to the Site; (f) systematically (including manually) collect, scrape, or use any content from the Site or Service, including through the use of any data mining, or similar data gathering and extraction methods; (g) use any high volume, automated, or electronic means to access the services (including without limitation robots, spiders, or scripts); (h) frame the Site, place pop-up windows over its pages, or otherwise affect the display of its pages; or (i) assist, encourage, or enable violations of this Agreement.
You may not disobey any requirements, procedures, policies, or regulations of networks connected to the Site.
You agree not to use the Site or access the Site for any purposes other than for which the Site is being provided to You. Use of the Site requires that You comply with further acceptable use policies we may establish from time to time.
5. FRAUD PROTECTION.
We reserve the right to refuse to process any transaction due to suspected fraud or unauthorized or illegal activity. We also reserve the right to cancel any accounts or refuse to ship to certain addresses due to suspected fraud or unauthorized or illegal activity.
6. MONITORING AND ENFORCEMENT.
We have the right to:
- Remove or refuse to post any User Contribution for any or no reason in our sole discretion.
- Take any action with respect to any User Contribution that we deem necessary or appropriate in our sole discretion, including if we believe that such User Contribution violates these Terms, infringes any intellectual property right or other right of any person or entity, threatens the personal safety of users of the Site or the public, or could create liability for LEADIANT.
- Disclose Your identity or other information about You to any third party who claims that material posted by You violates their rights, including their intellectual property rights or their right to privacy.
- Take appropriate legal action, including, without limitation, referral to law enforcement, for any illegal or unauthorized use of the Site.
- Terminate or suspend your access to all or part of the Website for any or no reason, including, without limitation, any violation of these Terms.
Without limiting the foregoing, we have the right to cooperate fully with any law enforcement authorities or court order requesting or directing us to disclose the identity or other information of anyone posting any materials on or through the Site. YOU WAIVE AND HOLD HARMLESS LEADIANT AND ITS AFFILIATES FROM ANY CLAIMS RESULTING FROM ANY ACTION TAKEN BY ANY OF THE FOREGOING PARTIES DURING OR AS A RESULT OF ITS INVESTIGATIONS AND FROM ANY ACTIONS TAKEN AS A CONSEQUENCE OF INVESTIGATIONS BY EITHER SUCH PARTIES OR LAW ENFORCEMENT AUTHORITIES.
7. MODIFICATIONS TO THE SITE.
The content on the Site may not necessarily be complete or up-to-date, and we reserve the right to modify or discontinue the Site or services with or without notice to You. We will not be liable to You or any third party should we exercise our right to modify or discontinue the Site. If You object to any such changes, Your sole recourse will be to cease using the Site.
9. INFORMATION ON OUR SITE.
Although we make reasonable efforts to update the information on our site, we make no representations, warranties, or guarantees, whether express or implied, that any information or other content of the Site are accurate, complete, reliable, updated, current, or error-free. Any reliance You place on such information and other content is strictly at Your own risk. Despite our efforts, it is possible that information on our Site may be inaccurate. If LEADIANT determines that information on our Site is inaccurate, LEADIANT reserves the right to take any action it deems reasonable and necessary, in its sole discretion, to rectify the error. You agree to notify LEADIANT immediately if You become aware of any errors or inconsistencies with any transactions You undertake through the Site and comply with any corrective action taken by LEADIANT.
10. THIRD PARTY CONTENT.
Parties other than LEADIANT may offer and provide content, products, and services on or through the Site. Except for LEADIANT-branded content, products, or services that are identified as being offered by LEADIANT, LEADIANT does not operate, control, or endorse any content, products, or services on the Site or accessible through the Site in any way. LEADIANT is not responsible for examining or evaluating, and LEADIANT does not warrant the offerings of, any of these businesses or individuals or the content of their websites. LEADIANT does not assume any responsibility or liability for the actions, products, and content of all these and any other third parties. We are not responsible for any materials (including, without limitation, any content, data, software, information, products, or services) contained on or provided through such sites, or the appropriateness, decency, legality, copyright compliance, accuracy, or any other aspect of such sites; and we will not be liable for any loss or damage that may arise from Your use of them. You should carefully review their privacy statements and other conditions of use.
Our provision of a link to any other website or location is for Your convenience and does not signify our endorsement of such other site or location or its contents, including links contained in advertisements, such as banner advertisements and sponsored links. We have no control over, do not review, and cannot be responsible for, these outside websites or their content. Access to any other websites linked to the Site is at Your own risk. When leaving the Site, You should carefully review the applicable terms and policies, including privacy and data gathering practices, of that third party website. WE WILL NOT BE LIABLE FOR ANY INFORMATION, SOFTWARE, OR LINKS FOUND AT ANY OTHER WEBSITE, INTERNET LOCATION, OR SOURCE OF INFORMATION, NOR FOR YOUR USE OF SUCH INFORMATION, SOFTWARE, OR LINKS, NOR FOR THE ACTS OR OMISSIONS OF ANY SUCH WEBSITES OR THEIR RESPECTIVE OPERATORS.
12. COPYRIGHTS; RESTRICTIONS ON USE.
LEADIANT strives to ensure that the information contained in this web site is accurate and reliable. The entire content of the www.leadiant.com Site is ©2019 by LEADIANT. None of our content may be copied, modified, reproduced, republished, posted, transmitted, sold, offered for sale, or redistributed in any way without our prior written permission and the prior written permission of our applicable licensors. Nothing in these Terms grants You any right to receive delivery of a copy of or obtain access to our content, except as generally and ordinarily permitted through the Site according to this Agreement. Notwithstanding the foregoing, You may download or print single copies of Materials for Your personal, non-commercial use only, provided You keep intact all copyright and other proprietary notices.
If You have copyright concerns about any Materials or other content posted on the Site, please let us know. We comply with the provisions of the Digital Millennium Copyright Act that apply to us. If You have any complaints or objections to content posted on the Site, please contact our Designated Agent at the Contact Information below.
13. USER CONTRIBUTIONS.
The Site may contain message boards, chat rooms, forums, bulletin boards and certain other interactive features (collectively, “Interactive Services”) that allow users to post, submit, publish, display, or transmit to other users or other persons (“post”) content or materials (collectively, “User Contributions”) on or through the Site. Unless otherwise set forth on this Site, any non-personal information, communications, and/or material you send to this Site or to us by email or other means is provided on a non-confidential and non proprietary basis, and you grant us and other users of the site a non-exclusive, royalty-free, perpetual, world-wide, irrevocable, sub-licensable and transferable right and license to use, reproduce, create derivative works of, distribute, or publicly display any such information freely, and for any purpose whatsoever. Specifically, we will be free to use any ideas, concepts, know-how, or techniques contained in such information for any purpose, including developing, manufacturing, or marketing products or services.
You represent and warrant that: (a) You own or control all rights in and to the User Contributions and have the right to grant the license granted above; and (b) all of your User Contributions do and will comply with these Terms.
We are not responsible or liable to any third party for the content or accuracy of any User Contributions posted by You or any other user of the Site.
LEADIANT may terminate Your use of the Site and/or Your Account for any reason at any time. You understand that termination of this Agreement and Your Account may involve deletion of Your information from our databases as well as any content that You uploaded to the Site using such Account. YOU AGREE THAT WE WILL NOT BE LIABLE TO YOU OR ANY OTHER PARTY FOR ANY TERMINATION OF YOUR ACCESS TO THE SITE OR DELETION OF YOUR ACCOUNT OR CONTENT UPLOADED BY YOU.
15. DISCLAIMER OF WARRANTIES.
YOU EXPRESSLY AGREE THAT USE OF THE SITE IS AT YOUR SOLE RISK. THE SITE IS PROVIDED ON AN AS-IS AND AS-AVAILABLE BASIS. WHILE WE ATTEMPT TO INCLUDE ACCURATE AND UP TO DATE MATERIALS AND TO IDENTIFY VIRUSES THAT MAY BE PLACED ON THE WEBSITE BY THIRD PARTIES, TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW, LEADIANT EXPRESSLY DISCLAIMS ALL WARRANTIES OF ANY KIND, WHETHER EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR USE OR PURPOSE, NON-INFRINGEMENT, TITLE, OPERABILITY, CONDITION, QUIET ENJOYMENT, VALUE, SECURITY, RELIABILITY, ACCURACY OF DATA AND SYSTEM INTEGRATION. LEADIANT MAKES NO WARRANTY THAT THE SITE WILL MEET YOUR REQUIREMENTS, OR THAT THE SITE WILL BE ACCURATE, RELIABLE, CORRECT, USEFUL, TIMELY, UNINTERRUPTED, SECURE, DEFECT-FREE, OR ERROR-FREE (INCLUDING, WITHOUT LIMITATION, FREE FROM VIRUSES, WORMS, TROJANS, OTHER MALICIOUS CODE, OR OTHER HARMFUL COMPONENTS); NOR DOES LEADIANT MAKE ANY WARRANTY AS TO THE RESULTS THAT MAY BE OBTAINED FROM THE USE OF THE SITE, OR THAT DEFECTS IN THE SITE WILL BE CORRECTED. YOU UNDERSTAND AND AGREE THAT ANY MATERIAL DOWNLOADED OR OTHERWISE OBTAINED THROUGH THE USE OF THE SITE IS DONE AT YOUR OWN DISCRETION AND RISK AND THAT YOU WILL BE SOLELY RESPONSIBLE FOR ANY DAMAGE TO YOUR COMPUTER SERVICES OR LOSS OF DATA THAT RESULTS FROM THE DOWNLOAD OF SUCH MATERIAL AND/OR INFORMATION. NO ADVICE OR INFORMATION, WHETHER ORAL OR WRITTEN, OBTAINED BY YOU FROM LEADIANT OR THROUGH THE SITE WILL CREATE ANY WARRANTY NOT EXPRESSLY MADE HEREIN. IN JURISDICTIONS NOT ALLOWING THE EXCLUSION OR LIMITATION OF CERTAIN WARRANTIES, OUR AND OUR SUBSIDIARIES, AFFILIATES, LICENSORS, AND SUPPLIERS LIABILITY WILL BE LIMITED TO THE MAXIMUM EXTENT PERMITTED BY LAW.
16. LIMITATION OF LIABILITY.
YOU ACKNOWLEDGE AND AGREE THAT TO THE EXTENT PERMITTED BY LAW IN NO EVENT WILL LEADIANT OR ITS OFFICERS, EMPLOYEES, DIRECTORS, PARENTS, SUBSIDIARIES, AFFILIATES, AGENTS, LICENSORS, AND/OR SUPPLIERS BE LIABLE FOR ANY INDIRECT, INCIDENTAL, SPECIAL, CONSEQUENTIAL, EXEMPLARY, PUNITIVE, OR OTHER DAMAGES, INCLUDING, BUT NOT LIMITED TO, DAMAGES FOR LOSS OF REVENUES, PROFITS, GOODWILL, USE, DATA, OR OTHER INTANGIBLE LOSSES (EVEN IF SUCH PARTIES WERE ADVISED OF, KNEW OF OR SHOULD HAVE KNOWN OF THE POSSIBILITY OF SUCH DAMAGES, AND NOTWITHSTANDING THE FAILURE OF ESSENTIAL PURPOSE OF ANY LIMITED REMEDY), ARISING OUT OF OR RELATED TO YOUR USE OF THE SITE, REGARDLESS OF WHETHER SUCH DAMAGES ARE BASED ON CONTRACT, TORT (INCLUDING NEGLIGENCE AND STRICT LIABILITY), WARRANTY, STATUTE, OR OTHERWISE AND EVEN IF WE AND/OR OUR SUBSIDIARIES, AFFILIATES, LICENSORS, AND/OR SUPPLIERS HAS OR HAVE BEEN ADVISED OF THE POSSIBILITY OF DAMAGES. IF YOU ARE DISSATISFIED WITH ANY PORTION OF THIS SITE, YOUR SOLE AND EXCLUSIVE REMEDY IS TO DISCONTINUE USE OF THE SITE. THE AGGREGATE LIABILITY OF LEADIANT TO YOU FOR ALL CLAIMS ARISING FROM OR RELATED TO THE SITE OR THE SERVICES IS LIMITED TO THE LESSER OF (I) THE AMOUNT OF FEES ACTUALLY PAID BY YOU FOR USE OF THE SITE OR (II) ONE HUNDRED DOLLARS (U.S. $100.00). Some jurisdictions do not allow the exclusion of certain warranties or the limitation or exclusion of liability for incidental or consequential damages. Accordingly, some of the above limitations and disclaimers may not apply to You. To the extent that we may not, as a matter of applicable law, disclaim any implied warranty or limit our liabilities, the scope and duration of such warranty and the extent of our liability will be the minimum permitted under such applicable law.
To the extent permitted by law, You agree to indemnify, defend and hold harmless LEADIANT, its parents, subsidiaries, affiliates, officers, directors, licensors, co-branders, suppliers, and other partners, employees, consultants and agents, together with all of their respective officers, directors, employees and consultants, from and against any and all claims, liabilities, damages, losses, costs, expenses, fees (including reasonable attorneys’ fees and court costs) that such parties may incur as a result of or arising from (a) any information You submit, post, or transmit through the Site, (b) Your use of the Site, (c) Your violation of this Agreement, (d) Your violation of any rights of any other person or entity or (e) any viruses, Trojan horses, worms, time bombs, cancelbots, or other similar harmful or deleterious programming routines input by You into the Site. We reserve the right to exclusively defend and control any such indemnification matters; and that you will fully cooperate with us in any such defense.
Certain of the names, logos, and other materials displayed on the Site may constitute trademarks, trade names, service marks, or logos (“Marks”) of LEADIANT or other entities. You are not authorized to use any such Marks. Ownership of all such Marks and the goodwill associated therewith remains with us or those other entities.
19. GEOGRAPHICAL RESTRICTIONS.
Laws and Regulatory requirements vary across countries and jurisdictions. The Site may not comply with legal requirements of all jurisdictions. You acknowledge and agree that if you are located in any jurisdiction in the world where any common, statutory, regulatory, codified, or other law, rule, or regulation makes accessing this site or any Material inappropriate or illegal, or subject to consents or permissions that you yourself have not obtained, or voids this Agreement in whole or in part, then you are not authorized to access this site or any Materials. By using these services, you agree to the transfer and processing of your Personal information to LEADIANT in and subject to the laws of the United States.
Our failure to exercise or enforce any right or provision of this Agreement will not constitute a waiver of such right or provision. If any provision of this Agreement is found by a court of competent jurisdiction to be invalid, the parties nevertheless agree that the court should endeavor to give effect to the parties’ intentions as reflected in the provision, and that the other provisions of these Terms remain in full force and effect. You agree that regardless of any statute or law to the contrary, any claim or cause of action arising out of or related to Your use of the Site or this Agreement must be filed within one (1) year after such claim or cause of action arose or be forever barred. The section titles in this Agreement are for convenience only and have no legal or contractual effect. You and we are acting as independent contractors, and nothing in this Agreement creates an agency or partnership. You may not assign Your rights under this Agreement without our prior written consent, and any attempted assignment will be null and void.
This Agreement may not be modified, in whole or in part, except by us and as otherwise might be specifically described elsewhere in this Agreement; and anything contained on or provided through this site that is inconsistent with or conflicts with the terms of this Agreement is superseded by the terms of this Agreement.
All limitations on liability explicitly set forth herein, will survive the expiration or earlier termination of this Agreement for any reason. Our (and our licensors’) proprietary rights (including any and all intellectual property rights) in and to our technology and content and the Site will survive the expiration or earlier termination of this Agreement for any reason.
Please report any violations of this Agreement to email@example.com
23. CONTACT INFORMATION.
We respect the intellectual property of others, and we ask you and all of our site users, affiliates, licensors and suppliers to do the same. If you believe that your copyrighted work has been copied and is accessible on this site in a way that constitutes copyright infringement, you may notify us by providing our copyright agent with all of the following information:
- The electronic or physical signature of the copyright owner, or the person or entity authorized to act on behalf of the copyright owner.
- A specific description of the copyrighted work claimed to be infringed.
- A specific description of the claimed infringing activity (including the specific web page address on this site).
- A specific description where the original or an authorized copy of the copyrighted work exists (including, for example, a specific web page address not on this site).
- Your name, address, telephone number and email address.
- A written statement by you that you have a good faith belief that the disputed use is not authorized by the copyright owner, the person or entity authorized to act on behalf of the copyright owner, or the law.
- A written statement by you, made under penalty of perjury, that all of the above information is accurate, and that you are the copyright owner or the person or entity authorized to act on behalf of the copyright owner.
Our agent for notices of claims of copyright infringement on this site may be reached as follows:
Senior Director of Legal Affairs &
Chief Compliance Officer
9841 Washingtonian Boulevard
Gaithersburg, MD 20878
Revcovi (elapegademase-lvlr) is indicated for the treatment of adenosine deaminase severe combined immune deficiency (ADA-SCID) in pediatric and adult patients.
Important safety information
Warnings and precautions:
- Injection site bleeding in patients with thrombocytopenia: Increased risk of local bleeding in patients with thrombocytopenia; should not be used if thrombocytopenia is severe.
- Delay in improvement of immune function: Protect immune deficient patients from infections until improvement in immune function.
The most commonly reported adverse reactions were cough and vomiting.
In addition, the following post-marketing reports for the same class of enzyme replacement therapy used in the treatment of ADA-SCID, may also be seen with Revcovi treatment:
- Hematologic events: hemolytic anemia, autoimmune hemolytic anemia, thrombocythemia, thrombocytopenia and autoimmune thrombocytopenia
- Dermatological events: injection site erythema, urticaria
Important monitoring information:
Treatment with Revcovi should be monitored by measuring trough plasma ADA activity and trough dAXP levels for maintenance of therapeutic targets. If a persistent decline in plasma ADA activity occurs, immune function and clinical status should be monitored closely, and precautions should be taken to minimize the risk of infection.
Please refer to Revcovi’s Full Prescribing Information.