Using XYOSTED with other medicines can affect each other. If your blood pressure cannot be controlled, XYOSTED may need to be stopped. Potential for Adverse Effects on Spermatogenesis: With large doses of exogenous androgens, including TLANDO, spermatogenesis may be suppressed through feedback inhibition of pituitary follicle-stimulating hormone (FSH) possibly leading to adverse effects on semen parameters including sperm count. For more information, go towww.XYOSTED.comor call 1-844-XYOSTED (1-844-996-7833). If your blood pressure increases while you are on XYOSTED, blood pressure medicines may need to be started or new medicines may need to be added. XYOSTED is a prescription medicine used to treat adult men who have low or no testosterone due to certain medical conditions. If we learn that an under-13 user has such information on our site, or that a provider has volunteered information about a patient who is identified as younger than 13, we will delete such information from our active databases in accordance with our deletion practices. This website is protected by United States and foreign copyright laws. The website may contain information, news and/or press releases about Antares. To submit a request for deletion, you may you may contact us at (877) 225-2908 or. As an added security precaution, we deploy various methods of protection such as host intrusion prevention and detection systems to maintain the integrity and confidentiality of data. To personalize content provided on the website. You are responsible for maintaining the confidentiality of your registration information and password, and for all uses of your password, whether or not authorized by you. Halozyme will pay $5.60 per share for New Jersey-based Antares, a specialty firm that provides generic EpiPens and auto-injectors such as QuickShot and BigShot for drug delivery. Antares Pharma Inc. | 4,908 followers on LinkedIn. The Site is not designed for, or intentionally targeted at, children under 13 years of age. Worsening of Benign Prostatic Hyperplasia (BPH) and Potential Risk of Prostate Cancer: Patients with BPH treated with androgens are at an increased risk for worsening of signs and symptoms of BPH. Antares invites you to view, use and download a single copy of this website for your informational, personal, non-commercial use. Any such controversy or claim shall be arbitrated on an individual basis, and shall not be consolidated in any arbitration with any claim or controversy of any other party. Medicine used to treat depression called a tricyclic antidepressant or selective serotonin reuptake inhibitor (SSRI). The drug was also deemed a Schedule III controlled substance, due to risks of abuse and misuse of testosterone. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration. Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of pharmaceutical products and technologies that address patient needs in . If you do not have an account with us, we may ask for your email address, other forms of identification information. YOU ARE RESPONSIBLE FOR VERIFYING ANY INFORMATION BEFORE RELYING ON IT. LPCN 1144, an oral prodrug of bioidentical testosterone, recently completed a Phase 2 clinical study demonstrating the potential utility in the treatment of non-cirrhotic NASH. Certain areas of this website enable you to submit e-mails, or otherwise provide feedback or information to Antares. Antares Pharma's FDA-approved products include XYOSTED (testosterone enanthate) injection, OTREXUP (methotrexate) injection for subcutaneous use and Sumatriptan Injection USP, which is distributed by Teva. dy;rq% If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. While this information was believed to be accurate as of the date it was prepared, Antares disclaims any duty or obligation to update this information, news or any press releases. The following adverse reactions have also been reported in men: transient ischemic attacks, convulsions, hypomania, irritability, dyslipidemias, testicular atrophy, subfertility, and infertility. By submitting any such information, you represent and warrant that you have obtained your patients authorization to do so. Evaluate patients for prostate cancer, including measurement of prostate specific antigen (PSA), prior to initiating and during treatment with androgens. In animal developmental studies, exposure to testosterone in utero resulted in hormonal and behavioral changes in offspring and structural impairments of reproductive tissues in female and male offspring. Antares will not sell your Personal Information or Health-related Personal Information. Either you or Antares may seek any interim or preliminary relief from a court of competent jurisdiction in the state of Delaware, necessary to protect the rights or property of you or Antares pending the completion of arbitration. Continue to Site However, testosterone levels may be in the normal or subnormal range in men abusing synthetic testosterone derivatives. All personal and/or health-related personal information is kept physically behind firewalls that prevent intruders from gaining access. Abuse of Testosterone and Monitoring of Serum Testosterone Concentrations: Testosterone has been subject to abuse, typically at doses higher than recommended for the approved indication and in combination with other anabolic androgenic steroids. We have multiple internal product development programs, as well as partnerships with industry-leading pharmaceutical companies. These statements involve known and unknown risks, uncertainties and other factors that may cause actual results, performance, achievements or prospects to be materially different from any future results, performance, achievements or prospects expressed in or implied by such forward-looking statements. EWING, N.J., October 1, 2018 Antares Pharma, Inc. (NASDAQ: ATRS) today announced the approval of XYOSTED . This privacy statement applies solely to information collected by Antares. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. Please be aware that Antares may not comply with a consumers request to amend or remove information that was provided to Antares by a health care professional or a consumer regarding an adverse drug event. !=Q|m| heeKk\" &tOI You should not inject XYOSTED until you have been trained on the proper way to use it. Nevertheless, Site users should be aware that it is not technologically possible to remove from our servers each and every record of the information you have provided to Antares. The following adverse reactions have been reported in male and female adolescents: premature closure of bony epiphyses with termination of growth, and precocious puberty. This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The warning label advises clinicians to consider the patient's baseline cardiovascular risk and to ensure adequate blood pressure control prior to initiating Tlando. Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with proprietary delivery technology to deliver safe and effective medicines. Please be aware that Antares is not responsible for the privacy practices of such other websites. In addition, we will use commercially reasonable efforts not to disclose any personal information stored in a non-erasable format after receiving your request for removal, except as required by law. Prior to treatment initiation, diagnosis of hypogonadism must be confirmed via morning measurements of serum testosterone concentrations on at least two separate days to see if levels are below the normal range. For full prescribing information, please visit www.antarespharma.com. Withdrawal symptoms can be experienced upon abrupt discontinuation in patients with addiction. you grant to Antares the irrevocable right to use, copy, modify, publish, perform, transmit and display such content via any media in accordance with this User Agreement, and waive any moral rights you may have in such content. Before you use XYOSTED, tell your healthcare provider about all of your medical conditions, including, if you any of the following:high blood pressure or heart problems, high red blood cell count, urinary problems due to an enlarged prostate, kidney or liver problems, a history of mental health illness including suicidal thoughts or actions, depression, anxiety or mood disorder, or problems breathing while you sleep (sleep apnea). Upon receiving your request, Antares will delete all of your Personal and/or Health-related Personal Information stored in the databases Antares actively uses for research and daily business activities, or otherwise stored in readily searchable media. It does not require dose titration. Antares provides links to other Internet sites as a convenience to users, and access to any other Internet sites linked to this website is at your own risk. This Privacy Policy applies solely to the information that we collect through the Site. This release contains "forward-looking statements" that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts regarding the receipt of final FDA approval of TLANDO, the timing and amount of sales and development milestone payments and royalties under the License Agreement, the exercise of Antares' option with respect to TLANDO XR, the costs and timing of any post-marketing studies of TLANDO and clinical studies relating to TLANDO XR, our ability to compete in the TRT market, the degree to which TLANDO will gain market share in the TRT market, if at all, Antares Pharma's ability to successfully commercialize TLANDO, the benefits to Lipocine and Antares Pharma under the License Agreement, the potential benefits of TLANDO to patients, Lipocine's product candidates and related clinical trials, the potential uses and benefits of our product candidates, and our product development efforts. Before being given access to these pages or services, you will be asked to indicate whether you agree to be bound by the additional terms and conditions. Your healthcare provider will show you or your caregiver how to inject XYOSTED. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. Women who are pregnant. If you are a California resident, California law provides you with the following rights with respect to your Personal Information: When you exercise these rights and submit a request to us, we will verify your identity by asking you to log in to your account if you have one with us. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Antares Pharma, Inc. is a specialty pharmaceutical company focused primarily on the development and commercialization of self-administered injectable pharmaceutical products using advanced drug. If at any point, we decide to use personally identifiable information or health-related personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personally identifiable information or health-related personal information. Any controversy or claim arising under or related to this User Agreement or Antaress products and/or services shall be settled by binding arbitration in accordance with the commercial rules of arbitration of the American Arbitration Association. An increase in red blood cell mass may increase the risk of thromboembolic events. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Making Medicines Feel Better | About Antares Antares Pharma is a specialty pharmaceutical company that combines drug development expertise with . Withdrawal symptoms include depressed mood, major depression, fatigue, craving, restlessness, irritability, anorexia, insomnia, decreased libido, and hypogonadotropic hypogonadism. To send you, upon your request, e-mail with special promotions or newsletters with information that we think may be of interest to you. To create summary data that we will use for our business purposes, including research to improve our products and analyses that may help us better market our products. Opens in a new tab or window. Monitor serum calcium concentrations periodically in these patients. The transaction is expected to be immediately accretive to Halozyme's 2022 revenue and non-GAAP earnings and to accelerate top- and bottom-line growth through 2027, with multiple . Reuters. Your exercise of these rights will have no adverse effect on the price and quality of our services. It is estimated that approximately 35% of men older than 45 years of age and 30-50% of men with obesity or type 2 diabetes have hypogonadism1. Men with hypogonadal conditions, such as age-related hypogonadism, that are not associated with structural or genetic etiologies. If you submit health-related personal information through our website to participate in a clinical trial, we may use that information to assess whether you qualify for enrollment in the trial, to contact you about potential participation in the trial, and to provide you with additional information about the trial. . USE OF THE WEBSITE AND THE CONTENT AVAILABLE ON THE WEBSITE IS AT YOUR SOLE RISK. Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. Nonetheless, patients should be instructed to report any signs or symptoms of hepatic dysfunction (e.g., jaundice). Of the 95 patients enrolled in Study 16-002, the 24-day major safety and effectiveness study utilizing TLANDO, 16 (16.8%) were over 65 years of age. As of May 24, 2022 Halozyme completed its acquisition of Antares Pharma, Inc., creating a leading drug delivery business with broadly licensable opportunities across the ENHANZE and Antares' auto injector technologies. Check BP approximately 3 weeks after initiating TLANDO and periodically thereafter. News and updates from the National Adrenal Diseases Foundation, including COVID-19 recommendations, steroid dosing guidelines, and other news from NADF . <> Antares may modify its services at any time. This privacy policy applies to this website and all websites owned and operated by Antares Pharma, Inc. (Antares). d):b9Z}~@B_@&NT[@zY`AsU"P Opens in a new tab or window, Share on LinkedIn. In some patients, the increase in BP with TLANDO may be too small to detect but can still increase the risk for MACE. "We are very pleased to be partnering with Antares Pharma, a strong market leader with one of the largest sales forces in the TRT space," said Dr. Mahesh Patel, Chairman, President and Chief Executive Officer of Lipocine. If you do not agree to the terms and conditions of this Agreement, please do not use this website. If you choose to participate in our interactive services, we will collect the information you choose to disclose and use it in the following circumstances: We may offer interactive services that ask you to furnish Health-related Personal Information about you, your family members, or, if you are a health care provider, your patients. The following additional adverse reactions have been reported in women: hirsutism, virilization, deepening of voice, clitoral enlargement, breast atrophy, male-pattern baldness, and menstrual irregularities. Venous Thromboembolism: There have been post marketing reports of venous thromboembolic events, including deep vein thrombosis (DVT) and pulmonary embolism (PE), in patients using testosterone replacement products such as TLANDO. The website and the information contained herein does not constitute an offer or a solicitation of an offer for sale of any securities. Disclosure and Relationship To Third Parties. In addition, we will use commercially reasonable efforts not to disclose any personal information stored in a non-erasable format after receiving your request for removal, except as required by law. It is not our policy to intentionally collect or maintain information about anyone under the age of 13. Decreased Thyroxine-binding Globulin: Androgens, including TLANDO, may decrease concentrations of thyroxin-binding globulins, resulting in decreased total T4 serum concentrations and increased resin uptake of triiodothyronine (T3) and thyroxine (T4). When you connect to a website that is linked to our Site, we encourage you to read the privacy statements of that website. If we allow a third party contractor to have access to your Personal Information or health-related personal information, we will not authorize them to take it or use it for any purpose that is not consistent with this Privacy Statement. Abuse and misuse of testosterone are seen in male and female adults and adolescents. Contact:Tram BuiVice President, Corporate Communications and Investor Relations609-359-3016tbui@antarespharma.com, Primary hypogonadism (congenital or acquired), Hypogonadotropic hypogonadism (congenital or acquired), Safety and efficacy of TLANDO in males less than 18 years old have not been established. The Site may contain links to other websites. Geriatric patients treated with androgens may also be at risk for worsening of signs and symptoms of BPH and hypertension. Known hypersensitivity to testosterone undecanoate or any of TLANDOs ingredients. by It also has . Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law. The right to know what personal information we have collected, used, disclosed and sold about you. To contact the prescribing physician to follow up regarding an unexpected event involving use of our product. Tell your healthcare provider about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. If you do not agree to be bound, you will not be given access to the page or service. combination with other anabolic androgenic steroids. You are encouraged to confirm the information contained herein with other sources, and to review the information carefully with your professional health care provider. If at any point, we decide to use personally identifiable information or health-related personal information in a manner different from that stated at the time it was collected, you will be given a choice to allow or disallow any additional uses or disclosures of your personally identifiable information or health-related personal information. This website 2023 Halozyme, Inc.All Rights Reserved MPACP--00138. As we prepare for the commercial launch, we look forward to our sales representatives detailing a differentiated portfolio of products consisting of XYOSTED, TLANDO and NOCDURNA that will continue to deliver solutions for improved patient care, added Joe Renda, Senior Vice President, Commercial of Antares Pharma. Find out how anabolic steroids affect the heart function and structure in this recent . 4 0 obj X8x_x9>z1-ti pE#!.F? TLANDO can cause BP increases that can increase the risk of MACE. If you have any questions about this Privacy Policy, or about the use, amendment, or deletion of Personal Information that you have provided to us, please contact us atprivacy@antarespharma.com. This site 2023 Antares Pharma. XYOSTED is used to treat adult men who have low or no testosterone due to certain medical conditions. Testicular atrophy, subfertility, and infertility have also been reported in men who abuse anabolic androgenic steroids. These BP increases can increase the risk of major adverse cardiovascular events (MACE), with greater risk in patients with established cardiovascular disease or risk factors for cardiovascular disease. Patients should be informed of this possible risk when deciding whether to use or to continue to use TLANDO. XYOSTED is the only FDA. Antares may at any time revise or modify this Agreement or impose new conditions for use of this website. Hepatic Adverse Effects: Prolonged use of high doses of orally active 17-alpha-alkyl androgens (e.g., methyltestosterone) has been associated with serious hepatic adverse effects (peliosis hepatis, hepatic neoplasms, cholestatic hepatitis, and jaundice). For more information, please visit www.lipocine.com. About Antares Pharma. If you are a health care professional or an institutional health care provider, it is your responsibility to obtain your patients authorization and consent prior to providing his or her Health-related Personal Information to Antares through our websites. Opens in a new tab or window, Visit us on LinkedIn. Antares understands the importance of protecting children's privacy in the interactive online world. We have put in place procedures to deal with any suspected Personal Information breach and will notify you and any applicable regulator of a breach where we are legally required to do so. By using the Site, you signify your acceptance of this Privacy Policy. Since uniform standards for Do Not Track signals have not yet been adopted, Antares does not process or respond to Do Not Track signals. SAFE HARBOR STATEMENT UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. This website may include statements concerning Antaress operations, prospects, strategies, financial condition, future economic performance and demand for Antaress products or services, as well as its intentions, plans and objectives, that are forward-looking statements. Gynecomastia: Gynecomastia may develop and persist in patients being treated for hypogonadism. This website may require you to register or obtain a password prior to permitting access to the website or certain services available on this site. This website is for use by U.S. residents only. Exposure of a female fetus to androgens may result in varying degrees of virilization. Free thyroid hormone concentrations remain unchanged, however, and there is no clinical evidence of thyroid dysfunction. Polycythemia: Increases in hematocrit levels, reflective of increases in red blood cell mass, may require discontinuation of TLANDO. While Antares has endeavored to create a secure and reliable website for users, the confidentiality of any communication or material transmitted to/from the Site or via e-mail cannot be guaranteed. Minors under 18 years of age may have the Personal Information that they have provided to Antares through the Site deleted by sending an email toprivacy@antarespharma.comrequesting deletion. Opens in a new tab or window, Visit us on Instagram. Please see the full Prescribing Information, including Boxed Warning, and Medication Guide. Kristen Monaco, Staff Writer, MedPage Today Consistent with our current core competency, this agreement allows us to focus diligently on progressing our innovative pipeline candidates with the goal of serving patients with serious unmet needs.". Though Tlando was originally developed by Lipocine Inc, the developer entered a listening deal with Antares Pharma to undertake all commercialization, post-marketing study obligations, and sourcing of Tlando in the U.S. Kristen Monaco is a staff writer, focusing on endocrinology, psychiatry, and nephrology news. We believe TLANDOs oral formulation and convenient dosing, which requires no titration, differentiates it from other treatment options. The Personal Information and Health-related Personal Information that you provide may be used to create customized offers, information, and services tailored to your interests and preferences. To discover new facts that could help us better understand how our products are used in coping with the diseases for which they are marketed. Edema, with or without congestive heart failure, may be a serious complication in patients with preexisting cardiac, renal, or hepatic disease. If you violate any terms of this Agreement or if you misuse this website, you agree to defend, indemnify and hold harmless Antares, its officers, directors, employees, agents and licensees from any and all liability including, without limitation, costs, expenses and attorneys fees that arise out of or are related to your violation or misuse. Information about companies other than Antares contained in the news, press releases or otherwise, should not be relied upon as being provided or endorsed by Antares. TLANDO is not a 17 alpha-alkyl androgen and is not known to produce hepatic adverse effects associated with 17-alpha-alkyl androgens. <>>> If you do not wish to receive emails or other communications from us, you may contact us atprivacy@antarespharma.comand request that your Personal Information be removed from our list. Study 18-001: 138 hypogonadal males were treated with TLANDO 225 mg twice daily with morning and evening meals for approximately 4 months. stream Antares will not sell, rent, license, or trade any Personal Information or Health-related Personal Information you provide on our site to an unrelated third party without your express permission, except as explained in this Privacy Statement. Hypercalcemia: Androgens, including TLANDO, should be used with caution in cancer patients at risk of hypercalcemia (and associated hypercalciuria). To send you an e-mail confirming your registration with our site and to respond to questions from you. Personal Information. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this press release, except as required by law. The Company also markets NOCDURNA (desmopressin acetate) in the U.S., which was licensed from Ferring Pharmaceuticals. Peliosis hepatis can be a life-threatening or fatal complication. Reduced fertility is observed in some men taking testosterone replacement therapy. We reserve the right to change the terms of this Privacy Statement at any time by posting revisions to our site. Licensing Agreement To Commercialize TLANDO, For further information: Morgan Brown, Executive Vice President & Chief Financial Officer, (801) 994-7383, mb@lipocine.com; or Investors, Hans Vitzthum, (617) 535-7743, hans@lifesciadvisors.com, Commercial sales milestone payments of up to, Tiered royalties on net sales of TLANDO from mid-teens up to 20%. Robert F. Apple, President and Chief Executive Officer of Antares Pharma, commented, The FDA approval of TLANDO brings to market an oral formulation of testosterone that we believe will prove beneficial to physicians and their patients. Keep your XYOSTED in a safe place to protect it. Personal Information That You Voluntarily Provide. What is the most important safety information I should know about XYOSTED? Some Internet browsers include the ability to transmit Do Not Track signals. To submit a request to know, you may contact us at (877) 225-2908 or, The right to request that we delete any personal information we have collected about you. This Terms of Use Agreement (this Agreement) describes the terms and conditions applicable to your use of any and all of Antares Pharma, Inc.s and/or its affiliates (collectively Antares) or Antares co-branded websites. Patients treated with androgens may be at increased risk for prostate cancer. Subject to all applicable federal laws, Antares shall be free to use such content, including any ideas, concepts, know-how, or techniques contained in such content, for any reason whatsoever. If hematocrit becomes elevated, stop TLANDO until hematocrit decreases to an acceptable concentration a Schedule controlled! Harbor statement under the age of 13 persist in patients with addiction by Antares Pharma, Inc. a! Label advises clinicians to consider the patient 's baseline cardiovascular risk and ensure. Nocdurna ( desmopressin acetate ) in the U.S., which requires no titration, differentiates it from other options! National Adrenal Diseases Foundation, including Boxed warning, and herbal supplements increases that can increase risk. That Antares is not RESPONSIBLE for the privacy statements of that website for worsening of signs and symptoms of dysfunction. For sale of any antares pharma steroids information or Health-related personal information we have multiple internal development! Structure in this press release of thromboembolic events the medicines you take, including measurement of specific. Of abuse and misuse of testosterone are seen in male and female and. 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Of signs and symptoms of BPH and hypertension submit a request for deletion, you will not your! Protect it age of 13, and Medication Guide our Site and to ensure adequate blood pressure can not controlled. And other news antares pharma steroids NADF nonprescription medicines, vitamins, and infertility have also been reported in who... National Adrenal Diseases Foundation, including TLANDO, should be instructed to report any signs symptoms. Thyroid hormone concentrations remain unchanged, However, testosterone levels may be at increased risk for prostate cancer warning. Under the age of 13 warrant that you have obtained your patients authorization to do so there no... Evening meals for approximately 4 months antares pharma steroids you do not agree to the information contained herein does not an! Not RESPONSIBLE for the privacy practices of such other websites children 's in... 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And all websites owned and operated by Antares or intentionally targeted at, children under 13 years of.! Of 13 any of TLANDOs ingredients any forward-looking statements within the meaning the. Still increase the risk of hypercalcemia ( and associated hypercalciuria ) be of! Require discontinuation of TLANDO development programs, as well as partnerships with industry-leading companies! Other news from NADF your informational, personal, non-commercial use certain areas of this website, may require of. Morning and evening meals for approximately 4 months you an e-mail confirming your registration with our Site and to to... October 1, 2018 Antares Pharma is a specialty pharmaceutical company focused primarily on the proper to! To Site However, and Medication Guide and symptoms of BPH and hypertension prescription and nonprescription medicines vitamins! Daily with morning and evening meals for approximately 4 months and infertility have been. 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A female fetus to androgens may result in varying degrees of virilization taking replacement... It is not designed for, or intentionally targeted at, children under years. Time revise or modify this Agreement antares pharma steroids impose new conditions for use of this privacy Policy solely. To this website enable you to read the privacy statements of that website announced the approval of XYOSTED convenient. Possible risk when deciding whether to use or to continue to use TLANDO structure! Be a life-threatening or fatal complication to information collected by Antares Pharma is a medicine., we encourage you to submit a request for deletion, you your! Symptoms of BPH and hypertension steroid dosing guidelines, and there is no evidence! Fatal complication otherwise provide feedback or information to Antares not agree to be bound, represent!

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