“Manufacturing Files” means the output of the Approved Design “Intellectual Property Rights” means all United States and worldwide trademarks, service marks, trade dress, copyrights, patents, trade secrets, rights under unfair competition and/or unfair trade practices laws, and all other intellectual and industrial property rights related thereto. “Indemnified party” has the meaning defined in Section 11.“Force Majeure” means acts of God, strikes, lockouts, or other industrial disturbances, acts of public enemies, wars, insurrections, riots, earthquakes, fires, storms, floods, inability with reasonable diligence to obtain materials, delay in transportation by common carrier, and any other causes not within the control of the party claiming a suspension which by the exercise of due diligence such party shall not have been able to avoid or overcome.“FDA” means the United States Food and Drug Administration or any successor agency.“Confidential Information” has the meaning defined in Section 17. 4, Subpart A) for combination products, as applicable. Part 820) for devices or current good manufacturing practices (21 C.F.R. “cGMP” means current good manufacturing practice requirements set forth in the quality systems (QS) regulation (21 C.F.R.“Buyer” means the person or entity that placed the Order.“Argen Onboarding Materials” means Argen’s materials that provide guidance and requirements to place a successful order for the manufacture of Clear Aligners with Argen.“Argen Standard Terms” means the Argen Standard Terms and Conditions located at.“Argen” means The Argen Corporation, including any division or subsidiary thereof.“Aligners” means the clear aligners manufactured by Argen pursuant to the Manufacturing Files.“Approved Design” means, in each case, the Proposed Design approved by a dental medical professional.“Aligner Design” means the design for clear aligners developed by Buyer or a third party engaged by Buyer for such purpose.“Aligner Terms” means these Terms and Conditions of Sale of Clear Aligners.As used in these Terms and Conditions of Sale for Clear Aligners: These Terms and Conditions of Sale for Clear Aligners apply to all Orders between Argen and Buyer for the manufacture and supply of Aligners by Argen using the Manufacturing Files supplied by Buyer for such Aligners and shall be effective as of the date of acceptance by Argen of Buyer’s Order. If my insurance is a Medicare plan, I understand that these supplies are not covered if I am receiving any kind of Home Health Services.TERMS AND CONDITIONS OF SALE FOR CLEAR ALIGNERS (MANUFACTURED BY ARGEN PER THIRD PARTY DESIGN)Īrgen manufactures custom clear Aligners designed to move teeth in small increments based on a treatment plan approved by a qualified medical dental professional. These supplies must be provided by my Home Health Service Provider. If I choose to accept them while under a Home Health Episode, as defined by CMS, I may be financially responsible for the cost of these items. I request that payment of authorized Medicare, Medicaid, and Private Insurance benefits be made payable to Wound Management for any services or products issued by Wound Management. This assignment of benefits may be revoked at any time. I authorize WOUND MANAGEMENT to provide supplies and/or services as ordered by my physician. I understand that I have the right to make decisions concerning my medical care, including the right to accept or refuse medical or surgical treatment or medical supplies. I authorize Wound Management to bill my Insurance for the supplies provided and understand that I may be responsible for any deductibles or coinsurance. Estimated patient responsibility can be obtained by contactimg our billing dept. My signature below acknowledges that I have received the statement of rights and responsibilities and it has been explained to me. SUPPLIER STANDARDS & NOTICE OF PRIVACY PRACTICES The patient rights and responsibilities may be found at You may also call to request the policy via mail. My signature below acknowledges that I have received a copy of the CMS (Medicare) Supplier Standards and a Notice of Privacy Practices. The Notice of Privacy Practices may be found at may also call to request the policy via mail. I authorize any holder of medical or other information about the below named client to release such information to Wound Management, the Centers for Medicare and Medicaid Services and it’s agents or any other payable insurance to whom application for payment has been made for services rendered to the below named client to any physicians, hospitals, other healthcare providers or facilities, institutions, or agencies providing treatment to the below named client.
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