By ordering any of the Align REGEN Systems™ named here as PRODUCTS you are agreeing that you have read, understand and agree to this disclaimer:
ALIGN REGEN SYSTEM LLC DISCLAIMER ALIGN REGEN SYSTEM LLC, MANUFACTURES EXPERIMENTAL RELAXATION DEVICES refer to as PRODUCTS (not limited to but including: Align REGEN+, Align REGEN V, Align REGEN PE and Align REGEN Custom - PRODUCTS) and are in the status of “patent pending.” As an exploratory company with limited “prior art” and non-existent official scientific studies, no claims are being implied or made to the efficacy or outcomes to be expected by the use of PRODUCTS. It is in the best interest of ALIGN REGEN SYSTEM LLC and potential PURCHASERS of PRODUCTS, that a COMPREHENSIVE DISCLAIMER AND USER/PURCHASER AGREEMENT (AGREEMENT) for ALIGN REGEN SYSTEMS LLC PRODUCTS be given to PURCHASERS. ALL REFERENCES TO OUTCOMES, EFFICACY, EXPERIMENTAL RESULTS AND SUCCESSES COULD BE COINCIDENTAL AND NO DIRECT CAUSATIVE CONNECTION TO PRODUCTS ARE CLAIMED. WHILE DOCUMENTATION SPEAKS DIRECTLY TO THE USE OF PRODUCTS AND IMMEDIATE (<30MIN) RESULTS FROM USE OF PRODUCTS, NO CLAIMS ARE MADE THAT THE EXPERIENCES DESCRIBED WILL BE THE EXPECTED RESULTS OR EXPERIENCES OF THE PURCHASER(S). ALL STATEMENTS IN PRODUCTS DOCUMENTATION ARE FAITHFUL AND TRUE TO THE EXPERIENCE OF THE PRIOR PURCHASER, USERS, CASE STUDY PARTICIPANTS, TRIAL MEMBER, CLINICAL PATIENT, OR OTHER USERS OF PRODUCTS referred to as SUBJECTS. ANY PERCENTAGES DATA REPORTED, TIME FRAMES USED, AND USE CASES QUANTITATIVE MEASURES (EXPERIENCES) ARE USED PURELY IN EFFORT TO REPORT FACTS AS RELATED BY SUBJECTS AND DO NOT CONSTITUTE A CLAIM OF EXPECTATION FOR PURCHASERS USE OF PRODUCTS, BUT ONLY TO CONVEY AS ACCURATELY AS POSSIBLE PRIOR EXPERIENCES OF SUBJECTS WHEN USING PRODUCTS. AS REPORTED BY SUBJECTS ALIGN REGEN SYSTEM LLC MAKES THE HIGHEST ETHICAL EFFORTS TO CONVEY SUBJECTS EXPERIENCES AS ACCURATELY AS POSSIBLE AND ALL QUOTES HAVE BEEN CLEARED WITH SUBJECTS PRIOR TO PUBLICATION IN DOCUMENTS WITH ABOVE LETTERHEAD DISTRIBUTED BY ALIGN REGEN SYSTEMS LLC. ALL EXPERIENCES PURELY RELAY INFORMATION AS IT HAS BEEN PRESENTED BY SUBJECTS DURING USE OF PRDUCTS AND THEIR EXPERIENCES AND SHOULD BE CONSIDERED CORRELATED ONLY AND NOT CAUSATIVE AS NO SCIENTIFIC CONTROLS HAVE BEEN IN PLACE TO ACCOUNT FOR OTHER FACTORS WHICH COULD CONTRIBUTE TO EXPERIENCES REPORTED BY SUBEJECTS (E.G. DIET, EXERCISE, MEDS, SUPPLEMENTS, ENVIRONMENT, LIFESTYLE, SLEEP, STRESS OR ANY OTHER INFLUENCE NOT ACCOUNTED FOR WHICH COULD HAVE INFLUENCED EXPERIENCES BY SUBJECTS WHILE USING PRODUCTS.) PLEASE READ ENTIRELY BEFORE PURCHASING OR USING PRODUCTS FROM ALIGN REGEN SYSTEM LLC. YOUR PURCHASE AND/OR USE CONSTITUTES FULL ACCEPTANCE OF ALL TERMS. SECTION A: EXPERIMENTAL DEVICE CLASSIFICATION This device is classified as an EXPERIMENTAL RESEARCH INSTRUMENT utilizing static magnetic field technology generated by permanent neodymium magnets in combination with proprietary inert noble gas compositions (limited to Neon, Helium, Xenon, Argon, Krypton, and residual purification elements including traces of oxygen and atmospheric constituents as commonly found in the air). This device operates without electrical power, contains no electronic components (unless equipped with a digital pressure gauge), has no on/off switches (besides removal of the magnet), and generates no electrical current or artificial electromagnetic fields. This device represents rediscovered historical technology that has NOT been subjected to modern scientific evaluation, peer review, clinical trials, laboratory testing, or validation by any contemporary scientific, medical, or regulatory authority. The device is provided solely as experimental research equipment for individual investigation and personal experimentation. SECTION B: REGULATORY AND APPROVAL STATUS This device has NOT been evaluated, tested, reviewed, approved, cleared, or registered by: • Food and Drug Administration (FDA) • Any state or federal medical regulatory board • Any scientific research institution or medical society • Any healthcare authority or medical organization • Any international regulatory body or health agency • Any clinical testing laboratory or research facility This device is NOT classified as a medical device, therapeutic equipment, treatment apparatus, or healthcare product under any regulatory framework. No regulatory submissions have been made, and no regulatory approvals have been sought or obtained. SECTION C: ABSOLUTE PROHIBITION OF MEDICAL CLAIMS ALIGN REGEN SYSTEMS LLC makes NO CLAIMS, representations, warranties, or suggestions, whether express, implied, or inferred, regarding any medical, therapeutic, healing, curative, preventive, diagnostic, or health-related benefits from this device. Any reference or use of these terms by AGENTS (ANYONE REPRESENTING ALIGN REGEN SYSTEMS LLC) of ALIGN REGEN SYSTEMS LLC should be considered reflective of SUBJECTS’ EXPERIENCES when using PRODUCTS as reported by SUBJECTS and ARE NOT claims of PRODUCTS future performance for non-SUBJECTS and/or future PURCHASER, but purely referred to as EXPERIENCES. We (ALIGN REGEN SYSTEMS LLC AND AGENTS) explicitly DO NOT claim, represent, or suggest that this device will: • Diagnose, treat, cure, prevent, or mitigate any disease, condition, or ailment • Improve, affect, or influence any medical condition or health problem • Provide therapeutic benefit or medical treatment of any kind • Heal, repair, or regenerate any biological tissue or system • Affect any physiological process or biological function • Improve vitality, wellness, or general health status • Decrease pain, inflammation, or any symptom • Influence neurological, muscular, or skeletal systems • Affect degenerative conditions or chronic illnesses • Provide any measurable health outcome or benefit. Any historical references to similar technology, documented uses, or reported outcomes are provided solely for educational and informational purposes and DO NOT constitute predictions, promises, or representations that this device will produce any similar or related results. SECTION D: EXPERIMENTAL RESEARCH NATURE AND RESULTS DISCLAIMER This device is based on historical technology concepts that have been rediscovered but NOT validated through modern scientific methods. While similar devices have been documented in historical literature with various reported user experiences, these historical accounts: • Are NOT scientific evidence of EFFICACY or SAFETY • Do NOT predict or guarantee results from this device • May be anecdotal, unverified, or coincidental • Have NOT been replicated under controlled conditions • Should NOT be considered reliable indicators of potential outcomes YOUR RESULTS MAY VARY DRAMATICALLY, including: • BENEFICIAL RESULTS: Possible but not predicted or expected • NO RESULTS: Most likely outcome for majority of users • ADVERSE RESULTS: Possible and unpredictable worse cases imaginable • PLACEBO EFFECTS: May account for any perceived benefits • COINCIDENTAL IMPROVEMENTS: May be unrelated to device use. A user experiences NO NOTICEABLE EFFECTS of any kind. Any positive experiences reported by other users are individual cases that may be entirely coincidental, related to placebo effect, lifestyle changes, other treatments, natural healing processes, or completely unrelated factors. SECTION E: MANDATORY MEDICAL CONSULTATION REQUIREMENT You are REQUIRED and REQUESTED to consult with qualified medical professionals before using this device, particularly if you have: • Any diagnosed medical conditions or health problems • Any symptoms requiring medical attention • Any prescription medications or medical treatments • Any implanted medical devices or equipment including pacemaker • Any chronic illnesses or degenerative conditions • Any history of adverse reactions to magnetic fields • Pregnancy or nursing status • Any concerns about device interaction with your health status. This consultation requirement is MANDATORY and NON-WAIVABLE. Failure to consult appropriate medical professionals before use constitutes misuse of this experimental device and ALIGN REGEN SYSTEM LLC will not be held liable for any outcome as a result of lack of action by PURCHASER. SECTION F: CONTRAINDICATIONS, WARNINGS, AND SAFETY INFORMATION ABSOLUTE CONTRAINDICATIONS (DO NOT USE, OR USE WITH EXPLICIT DOCTOR APPROVAL): • Individuals with pacemakers, defibrillators, or cardiac rhythm devices • Individuals with insulin pumps or medication delivery devices • Individuals with cochlear implants or hearing devices • Individuals with any implanted electronic medical equipment • Individuals advised against magnetic field exposure by physicians
POTENTIAL SIDE EFFECTS AND WARNINGS: • Lethargy or unusual fatigue with prolonged or excessive exposure • Unknown interactions with medications or medical conditions • Unpredictable individual responses to magnetic field exposure • Possible exacerbation of existing medical conditions USAGE PRECAUTIONS: • If lethargy occurs, immediately discontinue use for minimum of one week • Resume use only with significantly reduced exposure time at further distance or will less magnetism • Never place device in direct contact with implanted medical devices • Pregnant women must obtain physician approval before any use • Children under 18 require parental consent and medical consultation • Elderly individuals should use only under medical supervision SECTION G: COMPREHENSIVE ASSUMPTION OF RISK By purchasing, possessing, or using this device, you VOLUNTARILY AND KNOWINGLY ASSUME ALL RISKS associated with experimental device use, including but not limited to: • Risk of no beneficial results or effects • Risk of adverse reactions or negative effects • Risk of unknown interactions with medical conditions • Risk of interference with medical devices or treatments • Risk of wasted time, money, and expectations • Risk of delayed medical treatment due to reliance on experimental device • Risk of any and all consequences from experimental device use • Risk of self-injury as a result of less pain and exacerbating prior condition You acknowledge that experimental devices carry inherent, unpredictable risks that cannot be fully identified, predicted, or prevented. You accept full personal responsibility for all consequences of your decision to use this experimental equipment. SECTION H: COMPLETE LIMITATION OF LIABILITY AND DAMAGES ALIGN REGEN SYSTEMS LLC, its owners, beneficiaries, members, employees, contractors, representatives, affiliates, successors, AGENTS, and assigns SHALL NOT BE LIABLE under any legal theory for any damages, losses, injuries, or consequences arising from or related to: • Purchase, possession, or use of this device • Failure of device to produce any results or benefits • Any adverse effects or negative consequences from device use • Reliance on device instead of seeking medical treatment • Any direct, indirect, incidental, consequential, or punitive damages • Economic losses, medical expenses, or opportunity costs • Pain and suffering, emotional distress, or loss of enjoyment • Any claims by third parties affected by your device use This limitation applies regardless of legal theory, including negligence, strict liability, breach of warranty, or any other cause of action. This limitation applies even if ALIGN REGEN SYSTEMS LLC has been advised of the possibility of such damages. SECTION I: INDEMNIFICATION AND HOLD HARMLESS AGREEMENT You agree to INDEMNIFY, DEFEND, and HOLD HARMLESS ALIGN REGEN SYSTEMS LLC and all associated parties from any and all: • Claims, lawsuits, or legal actions arising from your device use • Damages, settlements, or judgments related to device use • Legal fees, court costs, and defense expenses • Third-party claims from individuals affected by your device use • Regulatory actions or investigations related to your device use This indemnification obligation survives termination of this agreement and continues indefinitely. SECTION J: MANUFACTURING AND QUALITY DISCLAIMERS While we maintain quality control standards for experimental device manufacturing, we explicitly disclaim all warranties regarding: • Device performance, reliability, or consistency • Manufacturing defects or variations in construction • Longevity, durability, or operational lifespan • Accuracy of magnetic field strength or gas composition • Batch-to-batch consistency or standardization WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING: • Warranties of merchantability or fitness for particular purpose • Warranties of non-infringement or title • Any warranties arising from course of dealing or usage of trade SECTION K: RETURN POLICY AND REFUND LIMITATIONS We offer a 50% refund of purchase price upon return of device in original condition if PURCHASER decides to discontinue experimental research. This return policy: • Does NOT constitute acknowledgment of defects or problems • Does NOT imply any guarantee of results or performance • Is offered solely as accommodation for research discontinuation • Requires return within 8 days of purchase • May be modified or discontinued without notice The 50% restocking fee covers minimal financial impact to ALIGN REGEN SYSTEM LLC. SECTION L: PROPRIETARY INFORMATION AND TRADE SECRETS The specific composition of inert gas mixtures, manufacturing processes, and technical specifications constitute proprietary trade secrets of ALIGN REGEN SYSTEMS LLC. You agree to: • Maintain confidentiality of any proprietary information disclosed • Not reverse engineer, analyze, or attempt to replicate the device • Not disclose technical specifications to third parties • Respect intellectual property rights in device design and composition SECTION M: GOVERNING LAW AND JURISDICTION This agreement is governed exclusively by Delaware state law without regard to conflict of law principles. Good faith efforts to resolve conflicts between ALIGN REGEN SYSTEM LLC and PURCHASERS via mediation is required as laws permit and required ALIGN REGEN SYSTEM LLC appointed mediator as agreed upon by PURCHASER signing this disclaimer. Any further disputes, claims, or legal actions must be brought exclusively in the State of Delaware courts. You consent to personal jurisdiction in Delaware courts and waive any objections to venue or jurisdiction. SECTION N: SEVERABILITY AND MODIFICATION If any provision of this agreement is deemed invalid or unenforceable, the remaining provisions remain in full force and effect. This agreement may only be modified in writing signed by authorized representatives of ALIGN REGEN SYSTEM LLC. SECTION O: ENTIRE AGREEMENT AND ACKNOWLEDGMENT This document (all three pages of which this is the 3rd) constitutes the entire agreement between parties regarding the experimental device. You acknowledge that: • You have read and understood all terms and conditions • You have had opportunity to consult legal and medical professionals • You are entering this agreement voluntarily and without coercion • You understand the experimental nature and risks of the device • You accept full responsibility for your decision to use experimental equipment • No oral representations or promises have been made beyond this written agreement SECTION P: REQUIRED USER ACKNOWLEDGMENT AND DIGITAL SIGNATURE By ordering any of these PRODUCTS You are acknowledging that you have carefully read, fully understand, and voluntarily agree to all terms and conditions set forth in this Experimental Wellness Device Comprehensive Disclaimer and User Agreement. You understand that this device is experimental research equipment with no guaranteed results, and you assume all risks associated with its use.
By ordering any of the Align REGEN Systems™ named here as PRODUCTS you are agreeing that you have read, understand and agree to this disclaimer:
ALIGN REGEN SYSTEM LLC DISCLAIMER ALIGN REGEN SYSTEM LLC, MANUFACTURES EXPERIMENTAL RELAXATION DEVICES refer to as PRODUCTS (not limited to but including: Align REGEN+, Align REGEN V, Align REGEN PE and Align REGEN Custom - PRODUCTS) and are in the status of “patent pending.” As an exploratory company with limited “prior art” and non-existent official scientific studies, no claims are being implied or made to the efficacy or outcomes to be expected by the use of PRODUCTS. It is in the best interest of ALIGN REGEN SYSTEM LLC and potential PURCHASERS of PRODUCTS, that a COMPREHENSIVE DISCLAIMER AND USER/PURCHASER AGREEMENT (AGREEMENT) for ALIGN REGEN SYSTEMS LLC PRODUCTS be given to PURCHASERS. ALL REFERENCES TO OUTCOMES, EFFICACY, EXPERIMENTAL RESULTS AND SUCCESSES COULD BE COINCIDENTAL AND NO DIRECT CAUSATIVE CONNECTION TO PRODUCTS ARE CLAIMED. WHILE DOCUMENTATION SPEAKS DIRECTLY TO THE USE OF PRODUCTS AND IMMEDIATE (<30MIN) RESULTS FROM USE OF PRODUCTS, NO CLAIMS ARE MADE THAT THE EXPERIENCES DESCRIBED WILL BE THE EXPECTED RESULTS OR EXPERIENCES OF THE PURCHASER(S). ALL STATEMENTS IN PRODUCTS DOCUMENTATION ARE FAITHFUL AND TRUE TO THE EXPERIENCE OF THE PRIOR PURCHASER, USERS, CASE STUDY PARTICIPANTS, TRIAL MEMBER, CLINICAL PATIENT, OR OTHER USERS OF PRODUCTS referred to as SUBJECTS. ANY PERCENTAGES DATA REPORTED, TIME FRAMES USED, AND USE CASES QUANTITATIVE MEASURES (EXPERIENCES) ARE USED PURELY IN EFFORT TO REPORT FACTS AS RELATED BY SUBJECTS AND DO NOT CONSTITUTE A CLAIM OF EXPECTATION FOR PURCHASERS USE OF PRODUCTS, BUT ONLY TO CONVEY AS ACCURATELY AS POSSIBLE PRIOR EXPERIENCES OF SUBJECTS WHEN USING PRODUCTS. AS REPORTED BY SUBJECTS ALIGN REGEN SYSTEM LLC MAKES THE HIGHEST ETHICAL EFFORTS TO CONVEY SUBJECTS EXPERIENCES AS ACCURATELY AS POSSIBLE AND ALL QUOTES HAVE BEEN CLEARED WITH SUBJECTS PRIOR TO PUBLICATION IN DOCUMENTS WITH ABOVE LETTERHEAD DISTRIBUTED BY ALIGN REGEN SYSTEMS LLC. ALL EXPERIENCES PURELY RELAY INFORMATION AS IT HAS BEEN PRESENTED BY SUBJECTS DURING USE OF PRDUCTS AND THEIR EXPERIENCES AND SHOULD BE CONSIDERED CORRELATED ONLY AND NOT CAUSATIVE AS NO SCIENTIFIC CONTROLS HAVE BEEN IN PLACE TO ACCOUNT FOR OTHER FACTORS WHICH COULD CONTRIBUTE TO EXPERIENCES REPORTED BY SUBEJECTS (E.G. DIET, EXERCISE, MEDS, SUPPLEMENTS, ENVIRONMENT, LIFESTYLE, SLEEP, STRESS OR ANY OTHER INFLUENCE NOT ACCOUNTED FOR WHICH COULD HAVE INFLUENCED EXPERIENCES BY SUBJECTS WHILE USING PRODUCTS.) PLEASE READ ENTIRELY BEFORE PURCHASING OR USING PRODUCTS FROM ALIGN REGEN SYSTEM LLC. YOUR PURCHASE AND/OR USE CONSTITUTES FULL ACCEPTANCE OF ALL TERMS. SECTION A: EXPERIMENTAL DEVICE CLASSIFICATION This device is classified as an EXPERIMENTAL RESEARCH INSTRUMENT utilizing static magnetic field technology generated by permanent neodymium magnets in combination with proprietary inert noble gas compositions (limited to Neon, Helium, Xenon, Argon, Krypton, and residual purification elements including traces of oxygen and atmospheric constituents as commonly found in the air). This device operates without electrical power, contains no electronic components (unless equipped with a digital pressure gauge), has no on/off switches (besides removal of the magnet), and generates no electrical current or artificial electromagnetic fields. This device represents rediscovered historical technology that has NOT been subjected to modern scientific evaluation, peer review, clinical trials, laboratory testing, or validation by any contemporary scientific, medical, or regulatory authority. The device is provided solely as experimental research equipment for individual investigation and personal experimentation. SECTION B: REGULATORY AND APPROVAL STATUS This device has NOT been evaluated, tested, reviewed, approved, cleared, or registered by: • Food and Drug Administration (FDA) • Any state or federal medical regulatory board • Any scientific research institution or medical society • Any healthcare authority or medical organization • Any international regulatory body or health agency • Any clinical testing laboratory or research facility This device is NOT classified as a medical device, therapeutic equipment, treatment apparatus, or healthcare product under any regulatory framework. No regulatory submissions have been made, and no regulatory approvals have been sought or obtained. SECTION C: ABSOLUTE PROHIBITION OF MEDICAL CLAIMS ALIGN REGEN SYSTEMS LLC makes NO CLAIMS, representations, warranties, or suggestions, whether express, implied, or inferred, regarding any medical, therapeutic, healing, curative, preventive, diagnostic, or health-related benefits from this device. Any reference or use of these terms by AGENTS (ANYONE REPRESENTING ALIGN REGEN SYSTEMS LLC) of ALIGN REGEN SYSTEMS LLC should be considered reflective of SUBJECTS’ EXPERIENCES when using PRODUCTS as reported by SUBJECTS and ARE NOT claims of PRODUCTS future performance for non-SUBJECTS and/or future PURCHASER, but purely referred to as EXPERIENCES. We (ALIGN REGEN SYSTEMS LLC AND AGENTS) explicitly DO NOT claim, represent, or suggest that this device will: • Diagnose, treat, cure, prevent, or mitigate any disease, condition, or ailment • Improve, affect, or influence any medical condition or health problem • Provide therapeutic benefit or medical treatment of any kind • Heal, repair, or regenerate any biological tissue or system • Affect any physiological process or biological function • Improve vitality, wellness, or general health status • Decrease pain, inflammation, or any symptom • Influence neurological, muscular, or skeletal systems • Affect degenerative conditions or chronic illnesses • Provide any measurable health outcome or benefit. Any historical references to similar technology, documented uses, or reported outcomes are provided solely for educational and informational purposes and DO NOT constitute predictions, promises, or representations that this device will produce any similar or related results. SECTION D: EXPERIMENTAL RESEARCH NATURE AND RESULTS DISCLAIMER This device is based on historical technology concepts that have been rediscovered but NOT validated through modern scientific methods. While similar devices have been documented in historical literature with various reported user experiences, these historical accounts: • Are NOT scientific evidence of EFFICACY or SAFETY • Do NOT predict or guarantee results from this device • May be anecdotal, unverified, or coincidental • Have NOT been replicated under controlled conditions • Should NOT be considered reliable indicators of potential outcomes YOUR RESULTS MAY VARY DRAMATICALLY, including: • BENEFICIAL RESULTS: Possible but not predicted or expected • NO RESULTS: Most likely outcome for majority of users • ADVERSE RESULTS: Possible and unpredictable worse cases imaginable • PLACEBO EFFECTS: May account for any perceived benefits • COINCIDENTAL IMPROVEMENTS: May be unrelated to device use. A user experiences NO NOTICEABLE EFFECTS of any kind. Any positive experiences reported by other users are individual cases that may be entirely coincidental, related to placebo effect, lifestyle changes, other treatments, natural healing processes, or completely unrelated factors. SECTION E: MANDATORY MEDICAL CONSULTATION REQUIREMENT You are REQUIRED and REQUESTED to consult with qualified medical professionals before using this device, particularly if you have: • Any diagnosed medical conditions or health problems • Any symptoms requiring medical attention • Any prescription medications or medical treatments • Any implanted medical devices or equipment including pacemaker • Any chronic illnesses or degenerative conditions • Any history of adverse reactions to magnetic fields • Pregnancy or nursing status • Any concerns about device interaction with your health status. This consultation requirement is MANDATORY and NON-WAIVABLE. Failure to consult appropriate medical professionals before use constitutes misuse of this experimental device and ALIGN REGEN SYSTEM LLC will not be held liable for any outcome as a result of lack of action by PURCHASER. SECTION F: CONTRAINDICATIONS, WARNINGS, AND SAFETY INFORMATION ABSOLUTE CONTRAINDICATIONS (DO NOT USE, OR USE WITH EXPLICIT DOCTOR APPROVAL): • Individuals with pacemakers, defibrillators, or cardiac rhythm devices • Individuals with insulin pumps or medication delivery devices • Individuals with cochlear implants or hearing devices • Individuals with any implanted electronic medical equipment • Individuals advised against magnetic field exposure by physicians
POTENTIAL SIDE EFFECTS AND WARNINGS: • Lethargy or unusual fatigue with prolonged or excessive exposure • Unknown interactions with medications or medical conditions • Unpredictable individual responses to magnetic field exposure • Possible exacerbation of existing medical conditions USAGE PRECAUTIONS: • If lethargy occurs, immediately discontinue use for minimum of one week • Resume use only with significantly reduced exposure time at further distance or will less magnetism • Never place device in direct contact with implanted medical devices • Pregnant women must obtain physician approval before any use • Children under 18 require parental consent and medical consultation • Elderly individuals should use only under medical supervision SECTION G: COMPREHENSIVE ASSUMPTION OF RISK By purchasing, possessing, or using this device, you VOLUNTARILY AND KNOWINGLY ASSUME ALL RISKS associated with experimental device use, including but not limited to: • Risk of no beneficial results or effects • Risk of adverse reactions or negative effects • Risk of unknown interactions with medical conditions • Risk of interference with medical devices or treatments • Risk of wasted time, money, and expectations • Risk of delayed medical treatment due to reliance on experimental device • Risk of any and all consequences from experimental device use • Risk of self-injury as a result of less pain and exacerbating prior condition You acknowledge that experimental devices carry inherent, unpredictable risks that cannot be fully identified, predicted, or prevented. You accept full personal responsibility for all consequences of your decision to use this experimental equipment. SECTION H: COMPLETE LIMITATION OF LIABILITY AND DAMAGES ALIGN REGEN SYSTEMS LLC, its owners, beneficiaries, members, employees, contractors, representatives, affiliates, successors, AGENTS, and assigns SHALL NOT BE LIABLE under any legal theory for any damages, losses, injuries, or consequences arising from or related to: • Purchase, possession, or use of this device • Failure of device to produce any results or benefits • Any adverse effects or negative consequences from device use • Reliance on device instead of seeking medical treatment • Any direct, indirect, incidental, consequential, or punitive damages • Economic losses, medical expenses, or opportunity costs • Pain and suffering, emotional distress, or loss of enjoyment • Any claims by third parties affected by your device use This limitation applies regardless of legal theory, including negligence, strict liability, breach of warranty, or any other cause of action. This limitation applies even if ALIGN REGEN SYSTEMS LLC has been advised of the possibility of such damages. SECTION I: INDEMNIFICATION AND HOLD HARMLESS AGREEMENT You agree to INDEMNIFY, DEFEND, and HOLD HARMLESS ALIGN REGEN SYSTEMS LLC and all associated parties from any and all: • Claims, lawsuits, or legal actions arising from your device use • Damages, settlements, or judgments related to device use • Legal fees, court costs, and defense expenses • Third-party claims from individuals affected by your device use • Regulatory actions or investigations related to your device use This indemnification obligation survives termination of this agreement and continues indefinitely. SECTION J: MANUFACTURING AND QUALITY DISCLAIMERS While we maintain quality control standards for experimental device manufacturing, we explicitly disclaim all warranties regarding: • Device performance, reliability, or consistency • Manufacturing defects or variations in construction • Longevity, durability, or operational lifespan • Accuracy of magnetic field strength or gas composition • Batch-to-batch consistency or standardization WE DISCLAIM ALL WARRANTIES, EXPRESS OR IMPLIED, INCLUDING: • Warranties of merchantability or fitness for particular purpose • Warranties of non-infringement or title • Any warranties arising from course of dealing or usage of trade SECTION K: RETURN POLICY AND REFUND LIMITATIONS We offer a 50% refund of purchase price upon return of device in original condition if PURCHASER decides to discontinue experimental research. This return policy: • Does NOT constitute acknowledgment of defects or problems • Does NOT imply any guarantee of results or performance • Is offered solely as accommodation for research discontinuation • Requires return within 8 days of purchase • May be modified or discontinued without notice The 50% restocking fee covers minimal financial impact to ALIGN REGEN SYSTEM LLC. SECTION L: PROPRIETARY INFORMATION AND TRADE SECRETS The specific composition of inert gas mixtures, manufacturing processes, and technical specifications constitute proprietary trade secrets of ALIGN REGEN SYSTEMS LLC. You agree to: • Maintain confidentiality of any proprietary information disclosed • Not reverse engineer, analyze, or attempt to replicate the device • Not disclose technical specifications to third parties • Respect intellectual property rights in device design and composition SECTION M: GOVERNING LAW AND JURISDICTION This agreement is governed exclusively by Delaware state law without regard to conflict of law principles. Good faith efforts to resolve conflicts between ALIGN REGEN SYSTEM LLC and PURCHASERS via mediation is required as laws permit and required ALIGN REGEN SYSTEM LLC appointed mediator as agreed upon by PURCHASER signing this disclaimer. Any further disputes, claims, or legal actions must be brought exclusively in the State of Delaware courts. You consent to personal jurisdiction in Delaware courts and waive any objections to venue or jurisdiction. SECTION N: SEVERABILITY AND MODIFICATION If any provision of this agreement is deemed invalid or unenforceable, the remaining provisions remain in full force and effect. This agreement may only be modified in writing signed by authorized representatives of ALIGN REGEN SYSTEM LLC. SECTION O: ENTIRE AGREEMENT AND ACKNOWLEDGMENT This document (all three pages of which this is the 3rd) constitutes the entire agreement between parties regarding the experimental device. You acknowledge that: • You have read and understood all terms and conditions • You have had opportunity to consult legal and medical professionals • You are entering this agreement voluntarily and without coercion • You understand the experimental nature and risks of the device • You accept full responsibility for your decision to use experimental equipment • No oral representations or promises have been made beyond this written agreement SECTION P: REQUIRED USER ACKNOWLEDGMENT AND DIGITAL SIGNATURE By ordering any of these PRODUCTS You are acknowledging that you have carefully read, fully understand, and voluntarily agree to all terms and conditions set forth in this Experimental Wellness Device Comprehensive Disclaimer and User Agreement. You understand that this device is experimental research equipment with no guaranteed results, and you assume all risks associated with its use.
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