Definitions. Capitalized terms not otherwise defined herein shall have the meanings ascribed to them in your VOBGetter Agreement (the “Services Agreement”).
Payment. All fees and charges associated with your account shall be payable whether or not the Application is used during the applicable payment period as set forth in your Services Agreement. You will pay all applicable taxes, including sales or use taxes, payable in respect of the goods and services provided under this Agreement and any penalties or interest owing on those taxes. leeRCM reserves the right to increase the Monthly Application Fees prior to the commencement of any renewal of the Term, with any such increases effective at Renewal. In the event payment is not made by the due date, leeRCM may discontinue your Service and/or charge the greater of $250 per month per invoice or a Five Percent (5%) late fee for each month each invoice remains unpaid, as allowed by law. A reconnection fee equal to one (1) month’s Service Fee shall be assessed to re-establish connection after termination due to non-payment. You shall pay all costs of collection, including but not limited to attorneys' fees and costs in legal proceedings.
Third-Party Payment. Fees and charges may be paid by a third party, with the consent of leeRCM, upon your execution of an authorization letter. Such third-party payment will remain in effect for the entire term that the third party provides services to you. You acknowledge and agree that (a) during such term, you shall not be billed by leeRCM for use of the Application, the cost of which shall be paid for entirely by the third party, and (b) that such third party shall not at any time attempt to bill, charge or recoup in any manner any fees and costs due and payable.
Professional Judgment; Professional Responsibility. You acknowledge and agree that the Application is not intended to be used as a diagnostic tool, to provide medical diagnoses or determinations, to determine correct billing codes, to guarantee availability of insurance coverage, or to guarantee assumptions of receipt of payment for services rendered. You are solely responsible for using due care and exercising your independent professional judgment with regard to patient payment code determination, and determination of insurance availability or payment. You acknowledge that you are solely responsible for ensuring that your users follow appropriate procedures, as required by law and professional standards, for medical records, data handling and coding in using the Application with respect to the creation, modification, backup and storage of medical, payment and administrative records. You will be solely responsible for the professional and technical services you provide. leeRCM makes no representations concerning the completeness, accuracy or utility of any information in the Application, or concerning the qualifications or competence of persons who placed it there. leeRCM has no liability for the consequences to you or your patients of your use of the Application.
License Grant. leeRCM grants to you and your Users a revocable, limited, personal, non-exclusive, nontransferable, non-sub licensable license (a "License") for the Term of your Agreement to: (a) access and use the Application; (b) possess and use electronic and hard-copy written materials of leeRCM such as manuals and guidelines for use of the Application ("leeRCM Materials"; as such materials become available), in each case only in conjunction with your lawful use of the Application hereunder.
Beta Features. If you are invited to access any beta features of the Service or you access any beta features of the Service, you acknowledge that: (a) such features have not been made commercially available by leeRCM; (b) such features may not operate properly, be in final form or fully functional; (c) such features may contain errors, design flaws or other problems; (d) it may not be possible to make such features fully functional; (e) use of such features may result in unexpected results, corruption or loss of data, or other unpredictable damage or loss; (f) such features may change and may not become generally available; and (g) leeRCM is not obligated in any way to continue to provide or maintain such features for any purpose in providing the ongoing Service. These beta features are provided AS IS, with all faults. You assume all risk arising from use of such features, including, without limitation, the risk of damage to your computer system or the corruption or loss of data.
leeRCM Intellectual Property. You shall have no right or interest in respect of any corporate names, trade names, trademarks, service marks, logo, symbol or copyrighted materials or patented or patent-pending processes ("Intellectual Property") owned by leeRCM, or of the goodwill associated with such Intellectual Property, and you hereby acknowledge that all such rights and goodwill are, and shall remain, vested in leeRCM.
Except as otherwise expressly permitted in writing by leeRCM, you will not reverse engineer, decompile, disassemble, or otherwise attempt to discover or reduce to human readable form the source code of the Service, except to the extent allowed under any applicable law. If applicable law permits such activities, any information so discovered must be promptly disclosed to leeRCM, and shall be deemed to be leeRCM’s confidential proprietary information. You will not access the service for the purposes of copying the flow, process, or any other Intellectual Property belonging to leeRCM for the purposes of incorporating any such intellectual property into a competitive product.
Indemnification. You hereby agree to indemnify, defend, and hold harmless leeRCM and other users, and leeRCM’s and their respective affiliates, officers, directors, employees and agents, from and against any claim, cost or liability, including reasonable attorneys’ fees, arising out of or relating to: (a) the use of the Application by you or your workforce; (b) any breach by you or your workforce of any representations, warranties or agreements contained in this Agreement; (c) the actions of any person gaining access to the Application under credentials assigned to you or a member of your workforce; (d) the actions of anyone using credentials assigned to you or any member of your workforce that adversely affects the Application or any information accessed through the Application; and (e) your negligent or willful misconduct, or that of any member of your workforce. Your indemnification obligations in this Agreement (including this Section) are cumulative, and are not intended to, nor do they, limit your indemnification obligations elsewhere in this Agreement or at law, even if such obligations arise or are occasioned or triggered by a single assertion, claim, circumstance, action, event or transaction.
De-Identification. We may de-identify information that you or your workforce input or upload onto the Application, and use and disclose de-identified information for any purpose whatsoever. In consideration of our provision of the Application, you hereby transfer and assign to leeRCM all right, title and interest in and to all such de-identified information.
Consent to Electronic Communication. You understand that leeRCM may send you communications or data regarding the Application, including but not limited to (a) notices about your use of the Application, including any notices concerning violations of use; (b) updates; and (c) promotional information and materials regarding products and services offered by leeRCM and any of its marketing partners, via electronic mail. leeRCM will give you the opportunity to opt out of receiving promotional information and materials, but you acknowledge that the use of email to provide notices and updates is essential to performance under this Agreement.
Services Warranty Disclaimer. ACCESS TO THE APPLICATION AND THE INFORMATION CONTAINED ON THE APPLICATION IS PROVIDED “AS IS” AND “AS AVAILABLE” WITHOUT ANY WARRANTY OF ANY KIND, AND LEERCM DISCLAIMS ALL WARRANTIES, EXPRESSED OR IMPLIED, STATUTORY OR OTHERWISE, INCLUDING BUT NOT LIMITED TO THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, NONINFRINGEMENT AND TITLE. YOU ARE SOLELY RESPONSIBLE FOR ANY AND ALL ACTS OR OMISSIONS TAKEN OR MADE IN RELIANCE ON THE APPLICATION OR THE INFORMATION IN THE APPLICATION, INCLUDING INACCURATE OR INCOMPLETE INFORMATION. LEERCM DOES NOT REPRESENT OR WARRANT THAT THE APPLICATION MATERIALS OR CONTENT WILL MEET THE REQUIREMENTS OF ANY PERSON OR WILL BE COMPATIBLE OR WORK WITH ANY OTHER SOFTWARE OR SYSTEMS OR OPERATE ERROR-FREE OR CONTINUOUSLY. YOU AGREE THAT LEERCM HAS MADE NO AGREEMENTS, REPRESENTATIONS OR WARRANTIES OTHER THAN THOSE EXPRESSLY SET FORTH IN THIS AGREEMENT, AND THAT NO FUTURE AGREEMENT, REPRESENTATION OR WARRANTY OF LEERCM WITH REGARD TO INFORMATION, GOODS OR SERVICES PROVIDED UNDER THIS AGREEMENT SHALL BE EFFECTIVE UNLESS EXPRESSLY STATED IN A WRITTEN AMENDMENT TO THIS AGREEMENT SIGNED BY LEERCM.
YOU HEREBY ACKNOWLEDGE THAT A QUOTE OF BENEFITS AND/OR AUTHORIZATION DOES NOT GUARANTEE PAYMENT OR VERIFY ELIGIBILITY. PAYMENT OF BENEFITS ARE SUBJECT TO ALL TERMS, CONDITIONS, LIMITATIONS, AND EXCLUSIONS OF THE MEMBER’S CONTRACT AT TIME OF SERVICE.
Carrier Lines. YOU ACKNOWLEDGE THAT ACCESS TO THE APPLICATION WILL BE PROVIDED OVER VARIOUS FACILITIES AND COMMUNICATIONS LINES, AND INFORMATION WILL BE TRANSMITTED OVER LOCAL EXCHANGE AND INTERNET BACKBONE CARRIER LINES AND THROUGH ROUTERS, SWITCHES, AND OTHER DEVICES (COLLECTIVELY, “CARRIER LINES”) OWNED, MAINTAINED, AND SERVICED BY THIRD-PARTY CARRIERS, UTILITIES, AND INTERNET SERVICE PROVIDERS, ALL OF WHICH ARE BEYOND LEERCM’S CONTROL. LEERCM ASSUMES NO LIABILITY FOR, OR RELATING TO, THE INTEGRITY, PRIVACY, SECURITY, CONFIDENTIALITY, OR USE OF ANY INFORMATION WHILE IT IS TRANSMITTED ON THE CARRIER LINES, OR ANY DELAY, FAILURE, INTERRUPTION, INTERCEPTION, LOSS, TRANSMISSION, OR CORRUPTION OF ANY DATA OR OTHER INFORMATION ATTRIBUTABLE TO TRANSMISSION ON THE CARRIER LINES. USE OF THE CARRIER LINES IS SOLELY AT YOUR RISK AND IS SUBJECT TO ALL APPLICABLE LOCAL, STATE, NATIONAL, AND INTERNATIONAL LAWS.
Unauthorized Access; Lost or Corrupt Data. LEERCM IS NOT RESPONSIBLE FOR UNAUTHORIZED ACCESS TO YOUR DATA, FACILITIES OR EQUIPMENT BY PERSONS USING THE APPLICATION OR FOR UNAUTHORIZED ACCESS TO, ALTERATION, THEFT, CORRUPTION, LOSS OR DESTRUCTION OF YOUR DATA FILES, PROGRAMS, PROCEDURES, OR INFORMATION THROUGH THE APPLICATION, WHETHER BY ACCIDENT, FRAUDULENT MEANS OR DEVICES, OR ANY OTHER MEANS. YOU ARE SOLELY RESPONSIBLE FOR VALIDATING THE ACCURACY OF ALL OUTPUT AND REPORTS, AND FOR PROTECTING YOUR DATA AND PROGRAMS FROM LOSS BY IMPLEMENTING APPROPRIATE SECURITY MEASURES. YOU HEREBY WAIVE ANY DAMAGES OCCASIONED BY LOST OR CORRUPT DATA, INCORRECT REPORTS, OR INCORRECT DATA FILES RESULTING FROM PROGRAMMING ERROR, OPERATOR ERROR, EQUIPMENT OR SOFTWARE MALFUNCTION, SECURITY VIOLATIONS, OR THE USE OF THIRD-PARTY SOFTWARE. LEERCM IS NOT RESPONSIBLE FOR THE CONTENT OF ANY INFORMATION TRANSMITTED OR RECEIVED THROUGH OUR PROVISION OF THE APPLICATION.
Limitation of Liability. TO THE MAXIMUM EXTENT PERMITTED BY APPLICABLE LAW AND EXCEPT WITH RESPECT TO A PARTY'S DUTIES OF CONFIDENTIALITY AND INDEMNIFICATION SET FORTH HEREIN, IN NO EVENT WILL EITHER PARTY BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES, WHETHER BASED ON BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE) OR OTHERWISE, WHETHER OR NOT SUCH DAMAGES ARE FORESEEABLE OR THAT PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGE. LEERCM SHALL HAVE NO LIABILITY FOR THE FINANCIAL LOSSES, DAMAGES, AND/OR PENALTIES SUSTAINED BY YOU DUE TO A FAILURE OF THE APPLICATION, CONTENT, IMPLEMENTATION SERVICE OR SUPPORT SERVICE TO COMPLY WITH AN APPLICABLE FEDERAL OR STATE STANDARD, INCLUDING BUT NOT LIMITED TO A STANDARD RELATED TO THE PROVISION OF PROFESSIONAL SERVICES. IN NO EVENT WILL LEERCM'S TOTAL LIABILITY TO YOU HEREUNDER EXCEED THE AGGREGATE FEES PAID OR PAYABLE UNDER THIS AGREEMENT IN THE TWELVE (12) MONTH PERIOD PRECEDING THE EVENT GIVING RISE TO THE CLAIM, NOT TO EXCEED $2,500. YOU AGREE THAT YOU MAY NOT CHALLENGE THIS PROVISION AS BEING UNREASONABLE.
Force Majeure. Neither Party will be responsible for its failure or delay in performing its obligations (other than an obligation to pay amounts when due) under this Agreement when and to the extent such failure or delay is caused by: acts of God, fire or explosion, labor stoppages or other industrial disturbances, actions of any government agency, shortage of materials, acts of terrorism, or the stability or availability of the Internet or a portion thereof, or such other similar event that is outside the reasonable control of the affected Party (each a "Force Majeure Event"). Notwithstanding the foregoing, if a Force Majeure event(s) continues for a period in excess of thirty (30) days, you shall have the right to, upon prior written notice to leeRCM, terminate the Agreement without any further obligation or liability, provided leeRCM has not resumed delivery of the affected Service prior to your delivery of such written notice of termination.
Severability. Any provision of this Agreement that shall prove to be invalid, void, or illegal, shall in no way affect, impair, or invalidate any other provision of this Agreement. Such other provisions shall remain in full force and effect and the unenforceable term or provision shall be replaced by such enforceable term or provision as comes closest to the intention underlying the unenforceable term or provision.
Waiver. No term of this Agreement shall be deemed waived and no breach excused, unless such waiver or consent shall be in writing and signed by the Party claimed to have waived or consented. Any consent by any Party to, or waiver of a breach by the other, whether expressed or implied, shall not constitute a consent to, waiver of, or excuse for any other different or subsequent breach.
Complete Understanding; Amendments. This Agreement contains the entire understanding of the Parties, and there are no other written or oral understandings or promises between the Parties with respect to the subject matter of this Agreement other than those contained or referenced in this Agreement. The most current version of this Agreement shall apply, and that this Agreement may be revised by leeRCM from time to time, without prior notice.
No Third-Party Beneficiaries. Nothing express or implied in this Agreement is intended to confer, nor shall confer, upon any person or entity other than the Parties and their respective successors or assigns any rights, remedies, obligations, or liabilities whatsoever.
Relationship between Parties. Nothing contained in this Agreement shall constitute or be construed to create, a partnership, joint venture, agency or any other relationship between the Parties besides that of independent contractors. Neither Party shall have authority to contract for or bind the other Party in any manner whatsoever.
Electronic Transactions. The Application gives you the ability to enter into agreements, authorizations, consents and applications, or engage in other transactions electronically. YOU ACKNOWLEDGE THAT YOUR ELECTRONIC SUBMISSIONS VIA THE APPLICATION IN CONNECTION WITH SUCH ACTIVITIES CONSTITUTE YOUR ACKNOWLEDGMENT THEREOF AND YOUR AGREEMENT AND INTENT TO BE BOUND BY SUCH AGREEMENTS AND TRANSACTIONS, AND APPLIES TO ALL RECORDS RELATING TO SUCH TRANSACTIONS. You represent and warrant that you have the authority to take such actions.
Assignment. You will have no right to assign your Agreement, in whole or in part, by sale of assets, merger, transfer of equity, operation of law or otherwise, without leeRCM’s prior written consent, which may be withheld at leeRCM’s sole and absolute discretion. Any attempt to assign your Agreement, without such consent, will be void, of no effect and shall constitute a breach of the Agreement and subject you to immediate termination of your Agreement. Subject to the foregoing, the Agreement will bind and inure to the benefit of each Party's successors and assigns.
Applicable Law. Your Services Agreement, any and all Addenda thereto, and this Agreement, shall be interpreted consistently with federal law applicable to the Parties, including but not limited to HIPAA and HITECH, provided that state law issues shall be exclusively interpreted according to the laws of the State of Florida, without regard to choice of law principles.
Dispute Resolution; Jurisdiction and Venue. The parties agree to resolve any controversy, dispute, or claim arising out of or relating to your purchase of any product or service from leeRCM by binding Arbitration administered by the American Arbitration Association, in Miami-Dade County, Florida. In the event of a dispute involving Intellectual Property, including copyright, trademark, trade secrets, or any other cause of action provided for by law, venue shall be proper in the appropriate Federal or State Court, as dictated by the cause of action, with jurisdiction over Miami-Dade County, Florida. The prevailing party in any dispute arising out of or related to this Agreement shall be awarded reasonable attorney's fees and other costs.
Headings. All section headings contained in this Agreement are to be considered for reference purposes only, and are not intended to define or limit the scope of any provisions of this Agreement.
This Business Associate Agreement (the “HIPAA Agreement”), effective upon the date of execution of Customer’s leeRCM Services Agreement (the “Effective Date”), is entered into by and between lee RCM, LLC (“leeRCM”) and the Customer, (Customer and leeRCM each a “Party” and collectively the “Parties”).
IN GENERAL - The term “breach” means the acquisition, access, use, or disclosure of PHI in a manner not permitted under subpart E of this part which compromises the security or privacy of the protected health information.
Any unintentional acquisition, access, or use of PHI by a workforce member or person acting under the authority of Customer or a business associate, if such acquisition, access, or use was made in good faith and within the scope of authority and does not result in further use or disclosure in a manner not permitted under subpart E of Part II, 45 C.F.R. Parts 160 and 164.
Any inadvertent disclosure by a person who is authorized to access PHI at Customer or a business associate to another person authorized to access PHI at the same Customer or business associate, or organized health care arrangement in which Customer participates, and the information received as a result of such disclosure is not further used or disclosed in a manner not permitted under subpart E of Part II, 45 C.F.R. Parts 160 and 164.
A disclosure of protected health information where Customer or leeRCM has a good faith belief that an unauthorized person to whom the disclosure was made would not reasonably have been able to retain such information.
“Designated Record Set” shall mean a group of records maintained by or for Customer that is (i) the medical records and billing records about Individuals maintained by or for Customer, (ii) the enrollment, payment, claims adjudication, and case or medical management record systems maintained by or for Customer; or (iii) used, in whole or in part, by or for Customer to allow its customers to make decisions about Individuals. As used herein the term “Record” means any item, collection, or grouping of information that includes PHI and is maintained, collected, used, or disseminated by or for Customer.
“Individually Identifiable Health Information” shall mean information that is a subset of health information, including demographic information collected from an Individual, and (i) is created or received by Customer or leeRCM on behalf of Customer; and (ii) relates to the past, present, or future physical or mental health or condition of an Individual; the provision of health care to an Individual; or the past, present or future payment for the provision of health care to an Individual; and identifies the Individual, or with respect to which there is a reasonable basis to believe the information can be used to identify the Individual.
“Payment” shall mean (i) except as prohibited by 45 C.F.R. § 164.502(a)(5)(i) the activities undertaken by Customer (“Covered Entity”) to obtain premiums or to determine or fulfill its responsibility for coverage and the provision of benefits under the Covered Entity’s health plan(s); or (ii) a covered health care provider or health plan’s activity to obtain or provide reimbursement for the provision of health care. Such activities include eligibility/coverage determinations, risk adjusting, billing, claims management and collection activities, health care data processing, reviews of health care services with respect to medical necessity, coverage under the Covered Entity’s health plans, appropriateness of care, or justification of charges; utilization review activities (including prior authorization), disclosure to consumer reporting agencies relating to the collection of premiums or reimbursement.
“Protected Health Information” or “PHI” shall mean Individually Identifiable Health Information that is (i) transmitted by Electronic Media, (ii) maintained in any medium constituting Electronic Media; or (iii) transmitted or maintained in any other form or medium. "Protected Health Information" shall not include (i) education records covered by the Family Educational Right and Privacy Act, as amended, 20 U.S.C. § 1232g, (ii) records described in 20 U.S.C. § 1232g(a)(4)(B)(iv), employment records held by Customer in its role as an employer; and regarding a person who has been deceased for more than 50 years.
"Program Agreement" collectively refers to and means leeRCM Gold Certified Biller Program Agreement entered between leeRCM and Customer.
Subcontractor" means a person to whom a business associate delegates a function, activity, or service, other than in the capacity of a member of the workforce of such business associate.
“Treatment” shall mean the provision, coordination, or management of health care and related services by one or more health care providers, including the coordination or management of health care by a health care provider with a third party, including Customer and/or leeRCM; consultation between health care providers relating to an Individual; or the referral of an Individual for health care from one health care provider to another.
Incorporation of agreements. The Program Agreement between Customer and leeRCM hereby incorporates the terms of this Agreement. In the event of conflict between the terms governing HIPAA and confidentiality of patient data and files between in the Program Agreement and this HIPAA Agreement, the terms and conditions of the HIPAA Agreement shall govern.
Use and Disclosure of PHI to Provide Services. Except as otherwise permitted by this Agreement, the Program Agreement or HIPAA, the Privacy Rule, the Security Rule or the American Recovery and Reinvestment Act of 2009 (the “Recovery Act”), leeRCM will use and disclose Protected Health Information only as permitted or required by the terms of this HIPAA Agreement, to the extent required to fulfill leeRCM’s obligations under the Program Agreement or to perform any other related function, activity or service specifically requested by Customer in writing, or as Required By Law. All other uses not authorized by this HIPAA Agreement are prohibited. Specifically, leeRCM is prohibited from using to harm or to the detriment of Customer any information learned or gathered by Customer as part of its performance of the HIPAA Agreement.
Take reasonable steps to ensure that its employees’ actions or omissions do not cause leeRCM to breach the terms of this HIPAA Agreement.
Document disclosures of PHI in accordance with 45 C.F.R. 164.528, in order for Customer to respond to a request from an Individual for an accounting of disclosures of PHI or in order for leeRCM to respond to a request for an accounting to the extent required by the Recovery Act.
Report to Customer in writing any use or disclosure of the PHI of which leeRCM becomes aware that is not permitted by this HIPAA Agreement within five days of leeRCM’s discovery of such use or disclosure.
Mitigate, to the extent practicable, any harmful effect that is known to leeRCM of a use or disclosure of PHI by leeRCM in violation of this HIPAA Agreement.
Enter into a written agreement with any Subcontractors or agents that receives, creates, maintains or transmits PHI received by leeRCM on behalf of Customer, binding such subcontractors or agents to the same restrictions, terms and conditions that apply to leeRCM pursuant to this HIPAA Agreement with respect to such PHI, including the requirement that the Subcontractor or agent, as applicable, implement reasonable and appropriate safeguards to protect any electronic PHI that is disclosed to it by leeRCM.
Upon Customer’s request and within 10 days of such request, provide to Customer all required information to permit Customer to respond to a request from an Individual for an accounting of disclosures of PHI in accordance with 45 C.F.R. 164.528.
Maintain the integrity of any PHI transmitted by or received from Customer.
Provide Customer or, as directed by Customer, to an Individual to whom the PHI relates, the rights of access, amendment, and accounting as set forth in 45 C.F.R. 164.524, 45 C.F.R. 164.526 and 45 C.F.R. 164.528.
Implement administrative, physical, and technical safeguards that reasonably and appropriately protect the confidentiality, integrity, and availability of the Electronic Protected Health Information that it creates, receives, maintains, or transmits on behalf of Customer. leeRCM shall implement policies and procedures regarding such safeguards.
Promptly report to Customer, in writing, any Security Incident of which leeRCM becomes aware.
Notify Customer of any Breach within 5 (five) days of discovery by leeRCM as required by federal law. Delay in notification may only be allowed under the Recovery Act § 13402(g) and 45 C.F.R. 164.412. The notice shall include the identification of each Individual whose unsecured PHI has been, or is reasonably believed by leeRCM to have been accessed, acquired, or disclosed during such Breach.
Comply with requested restrictions on the disclosure of PHI as communicated to leeRCM by Customer if the disclosure is to a health plan for the purposes of carrying out Payment or Health Care Operations (and is not for the purpose of carrying out Treatment) and the PHI pertains solely to a health care item or service for which the health care provider involved has been paid out of pocket in full.
If leeRCM maintains Electronic Health Records as that term is defined in Section 13400 of the Recovery Act and an Individual requests a copy of such records, transmit the electronic records directly to an entity or person designated by the Individual, provided that any such choice is clear, conspicuous, and specific. Any fee charged for such electronic records shall not exceed leeRCM’s labor costs.
If leeRCM knows of a pattern of activity or practice of Customer that constitutes a material breach or violation of Customer’s obligations under this HIPAA Agreement, unless Customer successfully takes steps to cure the Breach or end the violation after receipt of notice from leeRCM, then leeRCM shall terminate this HIPAA Agreement and the Program Agreement or, if not feasible, notify the Secretary.
To the extent leeRCM is carrying out one or more obligations of Customer under 45 C.F.R. Part 164, Subpart E, leeRCM shall comply with the requirements of Subpart E that apply to Customer in the performance of such obligation(s).
leeRCM shall keep such records and submit such compliance reports in such time and manner and containing such information as the Secretary may determine to be necessary to enable the Secretary to ascertain whether leeRCM has complied or is complying with the applicable administrative simplification provisions. leeRCM shall also cooperate with the Secretary if the Secretary undertakes an investigation or compliance review of the policies, procedures, or practices of leeRCM to determine whether leeRCM is complying with the applicable administrative simplification provisions.
Disclose PHI in its possession to third-parties for proper management and administration, or to fulfill any of its legal responsibilities under this HIPAA Agreement or the Program Agreement; provided that (i) the disclosures are Required By Law, as provided for in 45 C.F.R. § 164.103, or (ii) leeRCM has received written assurances from the third party that the PHI will be held confidentially, and used or further disclosed only as Required By Law or for the purpose for which it was disclosed to the third party, and that the third party will notify leeRCM of any instances of which it is aware in which the confidentiality of the PHI has been breached, as required under 45 C.F.R. § 164.504(e)(4).
De-identify any and all PHI, provided that the de-identification conforms to the requirements of 45 C.F.R. § 164.514(b), and further provided that leeRCM maintains the documentation required by 45 C.F.R. § 164.514(b), which may be in the form of a written assurance from leeRCM. Pursuant to 45 C.F.R. § 164.502(d), de-identified information does not constitute PHI and is not subject to the terms of the HIPAA Agreement.
Notify leeRCM in writing of any restriction to the use or disclosure of Protected Health Information that Customer has agreed to in accordance with 45 C.F.R. § 164.522 or a restriction pursuant to the Recovery Act § 13405 (a) to which Customer’s compliance was mandatory to the extent such restriction may affect leeRCM’s use or disclosure of Protected Health Information. Before agreeing to any restriction on use or disclosure permitted under 45 C.F.R. § 164.522, but not mandated under the Recovery Act § 13405(a), Customer shall advise leeRCM of the contemplated restrictions and leeRCM shall, as promptly as practicable, advise Customer of the additional costs Customer will incur to implement such restriction.
Notify leeRCM of any changes to, or withdrawal of, the consent or authorization of an Individual provided to Customer pursuant to 45 C.F.R. § 164.506 or § 164.508 to the extent such changes may affect leeRCM's ability to perform its obligations under this HIPAA Agreement.
Access to PHI. Within five (5) days of a request by Customer for access to PHI maintained by leeRCM, leeRCM shall make PHI available to Customer, or at the written direction of Customer, to an Individual to whom such PHI relates or his or her authorized representative. In the event any Individual requests access to PHI directly from leeRCM, leeRCM shall, within five (5) days, forward such request to Customer. Any denials of access to the PHI requested shall be the responsibility of Customer.
Amendment of PHI. leeRCM shall make PHI available to Customer and will amend PHI as instructed by Customer, in a manner consistent with the Privacy Rule within ten (10) days of receipt of a request from Customer for the amendment of patient’s PHI.
Accounting for Disclosures of PHI. Within thirty (30) days of notice by Customer to leeRCM that it has received a request for an accounting of disclosures of PHI, leeRCM shall make available to Customer such information as is in leeRCM’s possession required for Customer to satisfy the accounting of disclosures requirement set forth in the Privacy Rule. In the event the request for an accounting is delivered directly to leeRCM, leeRCM shall, within five (5) days, forward the request to Customer. It shall be Customer’s responsibility to prepare and deliver any such accounting requested.
Individual Rights Regarding Designated Record Sets. If leeRCM maintains any PHI that could be construed to be part of a Designated Record Set of Customer, leeRCM shall (i) provide access to, and permit inspection and copying of, PHI by Customer, or if directed by Customer, an individual who is the subject of the PHI under conditions and limitations required under 45 C.F.R. § 164.524, as it may be amended from time-to-time, and (ii) amend PHI maintained by leeRCM as requested by Customer. leeRCM shall respond to any request from Customer for access by an individual within five (5) days of such request and shall make any amendment requested by Customer within ten (10) days of such request. Any information requested under this Section 9 shall be provided in the form or format requested, if it is readily producible in such form or format. leeRCM may charge a reasonable fee based upon leeRCM’s labor cost in responding to a request for electronic information (or a cost-based fee for the production of non-electronic media copies). Customer shall determine whether a denial is appropriate or an exception applies. leeRCM shall notify Customer within five (5) days of receipt of any request for access or amendment by an individual. Customer shall determine whether to grant or deny access or amendment requested by the individual. leeRCM shall have a process in place for receiving requests for amendments and for appending such requests to the Designated Record Set, as requested by Customer.
Notwithstanding the above, leeRCM shall not permit access to any record if such access would violate leeRCM’s ethical responsibilities or any other privilege that may be applicable to leeRCM. To the maximum extent permitted by law, Customer hereby reserves and retains any and all privileges in which Customer has an interest with respect to leeRCM’s performance of its obligations under this section. The parties acknowledge that Customer retains the right to waive any privilege with regard to its own records and to expressly instruct leeRCM to provide access to those records as a result of that waiver. In the event Customer decides to waive any privilege, Customer shall provide leeRCM with written notice of that waiver before leeRCM shall act on such decision.
Records and Audit. If leeRCM receives a request, made by or on behalf of HHS, requiring leeRCM to make available its internal practices, books, and records relating to the use and disclosure of PHI to HHS for the purpose of determining compliance of Customer with the Privacy Standards, then leeRCM shall promptly notify Customer that leeRCM has received such request. Except as otherwise set forth below, leeRCM shall make its books and records relating to the use and disclosure of PHI by Customer available to HHS and its authorized representatives for purposes of determining compliance of Customer with the Confidentiality Requirements.
To the maximum extent permitted by law, Customer hereby reserves and retains any and all privileges in which Customer has an interest with respect to leeRCM’s performance of its obligations under this Section 10. leeRCM, to the maximum extent permitted by law, hereby reserves and retains any and all privileges or rights. This section shall not be construed to require leeRCM to disclose or produce communications subject to any privileges or rights with respect to materials that analyze, evaluate or discuss the implications of PHI. Notwithstanding the above, in no event shall leeRCM delay complying with a request of HHS or its authorized representatives if such delay appears reasonably likely to result in any penalty, fine or other liability being levied or imposed upon Customer (such likelihood to be determined in the sole discretion of Customer), and Customer has instructed leeRCM in writing to disclose the information requested by HHS or its authorized representatives. The Parties acknowledge that Customer retains the right to: (i) waive any privilege with regard to books and records, and (ii) expressly instruct leeRCM to provide HHS and its authorized representatives with such books and records in the event of such waiver.
Government Access. leeRCM will make its internal policies, procedures, books, and records relating to use and disclosure of PHI (excluding the actual PHI) received from, or created or received by leeRCM on behalf of Customer, available to the Secretary for purposes of determining Customer compliance with the HIPAA Privacy and Security Rules, subject to any privileges covering leeRCM.
Automatic Termination. This HIPAA Agreement will automatically terminate without any further action of the Parties upon termination of leeRCM’s representation of Customer; provided, however, certain provisions and requirements of this HIPAA Agreement shall survive such expiration or termination in accordance with Section 15.
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As to the background of this case, please see the report about the hearing of 10 September 2018 on this Blog here.
Making a long(er) story short: The FPC granted interim injunctive relief to prohibit Sandoz from placing its generic version of Kivexa®, i.e. ‘Abacavir Lamivudine Sandoz®’, on the Swiss market. Noteworthy, Sandoz has apparently already lodged an appeal with the Supreme Court — long before the due date.
The decision is pretty straight-forward, at least at first glance. But still, it comes along with some quite pointed conclusions.
D1 (WO 96/06844) is not pre-published prior art, but might be relevant for the assessment of novelty under Art. 54(3) EPC 1973. The timeline is a bit tricky. The FPC holds that the priority claims of the patent in suit are valid, with particular reference to GB 9506490.3, claim 16. Still, D1 might be prior art under Art. 54(3) EPC if i) it had been further prosecuted before the EPO, and ii) the designation fees had been validly paid (R. 23a EPC 1973) — what is actually the case (see EPO Register), but had not been argued by the parties. The FPC thus left this issue undecided and did correctly not investigate this of its own motion. Rather, it moved on to the assessment of novelty vis-à-vis D1 as a matter of precaution, and held that novelty is given.
Interestingly, the German Federal Patent Court had apparently held in an interim assessment (which is not publicly available, to the best of my knowledge) that novelty was not given over D1. Now, how does the FPC explain the different outcome? That’s an interesting read, indeed. In a nutshell, the FPC bluntly notes that the standard of novelty is interpreted differently in Germany and at the European Patent Office — and that the FPC follows the approach taken by the EPO. Noteworthy, the FPC holds that the different standard is taken in particular with selection inventions. I am wondering: With all selection inventions, or only some kind of selection inventions? And what does in particular mean here? Is the different standard not even limited to selection inventions?
Dass das deutsche Bundespatentgericht in seiner vorläufigen Stellungnahme zu einem anderen Schluss gekommen ist, hängt damit zusammen, dass der Neuheitsbegriff in Deutschland anders interpretiert wird als vom Europäischen Patentamt, insbesondere [Anm.: Hervorhebung hinzugefügt] bei Auswahlerfindungen. Während beim europäischen Patentamt ein strenger Massstab angelegt wird hinsichtlich dessen, was im geltend gemachten Dokument des Standes der Technik für Neuheitsschädlichkeit offenbart sein muss (gewissermassen streng fotografischer Ansatz), wird gemäss deutscher Rechtsprechung ein grosszügigerer Massstab angelegt.4 D.h. ein Dokument ist gemäss deutscher Rechtsprechung bei Auswahlerfindungen eher neuheitsschädlich als gemäss Auffassung der Rechtsprechung der Beschwerdekammern des europäischen Patentamts.
Das Schweizer Bundespatentgericht folgt dem Ansatz der Beschwerdekammern des europäischen Patentamts, weswegen wie oben dargelegt Neuheit glaubhaft vorliegt.
4 Vgl. z.B. Moufang in Schulte, PatG, 10. Auflage, §3 Anm. 128 und 129.
The fact that the German Federal Patent Court came to a different conclusion in its provisional statement is due to the fact that the concept of novelty is interpreted differently in Germany than by the European Patent Office, in particular [Note: emphasis added] with regard to selection inventions. While the European Patent Office applies a strict standard with regard to what must be disclosed in the asserted prior art document in order to destroy novelty (to a certain extent a strictly photographic approach), according to German case law a more generous standard is applied.4 I.e. according to German case law a document is more harmful to novelty in selection inventions than according to the case law of the Boards of Appeal of the European Patent Office.
The Swiss Federal Patent Court follows the approach of the Boards of Appeal of the European Patent Office, which is why, as explained above, novelty is plausible.
4 See e.g. Moufang in Schulte, PatG, 10th edition, §3 Notes 128 and 129.
Practitioner may or may not share the FPC’s view in this respect. In any event, I feel that I have never seen this in writing, without any sugarcoat. Even Moufang in Schulte (referred to in fn 4 of the decision) only gives examples of decisions of the EPO and in Germany for closed numerical ranges, but does not draw any conclusions beyond that.
The decision holds that in the assessment of inventive step the question arises whether there was a motivation for the combination of the two active ingredients and a reasonable expectation that this combination would also show the same or at least comparable effectiveness, i.e. that it is effectively a valid alternative; see ¶4.8. But there is no reference in the decision why it should be done this way.
I have mentioned earlier on this Blog here that I do not readily agree with the cumulative application of both the motivation and reasonable expectation of success criteria. And I still don’t. But this issue is not relevant for the outcome of the present matter; the decision denies a motivation and does not deal at all with the issue of a reasonable expectation.
Is the plaintiff actually at risk of a ‘not easily repairable harm’ as required by Art. 261(1) lit. b CPC?
Defendant firmly insisted in the hearing of 10 September 2018 that this is not the case, with reference to an illustration similar to the one shown on the right. In brief, plaintiff ViiV Healthcare UK Ltd is the holder of the Swiss SPC, and is fully owned by ViiV Healthcare Ltd; cf the right branch of the illustration.
Likewise, ViiV Healthcare GmbH (holder of the Swiss MA for Kivexa® according to the ‘Spezialitätenliste‘) is fully owned by ViiV Healthcare Overseas Ltd, which in turn is fully owned by ViiV Healthcare Ltd; cf the left branch of the illustration.
Plaintiff has failed to provide prima facie evidence, let alone to state reasons, and to prove that he would suffer any damage which could not easily be remedied if the request for interim injunctive relief was refused. In particular, the defendant contests the allegations in para. 138-141 of the application, namely the allegations (i) that the applicant would suffer damage consisting of a decrease in the number of units sold in Switzerland; (ii) that the applicant would be affected by a price review by the Federal Office of Public Health; (iii) that the applicant would suffer financial losses in the event of a price review; and (iv) that the Federal Office of Public Health would require the applicant either to reduce the ex-works price of Kivexa® or to accept a higher deductible. In any event, the defendant cannot be held liable for any losses resulting from the market entry of a second generic manufacturer (see the allegations in paragraph 1. 139 of the application regarding Art. 38 of the Swiss Care Allowance Ordinance).
Paragraph 14 of the request for interim injunctive relief states that ViiV Healthcare GmbH (hereinafter ViiV Switzerland) is a group company and not a subsidiary of the plaintiff. According to the extract from the commercial register (act. 1_5), ViiV Switzerland is 100% owned by ViiV Healthcare Overseas Limited (UK), which is a 100% subsidiary of the parent company of the ViiV Group, ViiV Healthcare Limited. ViiV Healthcare Limited is the sole shareholder of the applicant.
The above had been submitted under the heading ‘Parties’, but apparently not in relation to the (lack of a) not easily repairable harm. The decision holds that the fact that the plaintiff itself does not suffer any damage due to the aforementioned corporate structure, but rather ViiV Switzerland, had not been asserted by the defendant in his written reply to the request for injunctive relief, but only for the first time at the hearing on 10 September 2018 — i.e., after the closure of the file after a single exchange of briefs (see decision 144 III 117 of the Supreme Court, ¶2.2).
But even if these allegations were admitted into the proceedings, the decision holds that a not easily repairable harm would be sufficiently credible. In the FPC’s view, it is ‘obvious and notorious’ that in such group constellations of pharmaceutical companies a disadvantage that cannot be easily repaired arises for the group and thus at least indirectly also for the formal holder of the SPC. The FPC failed to see why / to what extent this should not be the case in the present setup.
Es ist offensichtlich und notorisch, dass in derartigen Gruppenkonstellationen von pharmazeutischen Konzernen ein nicht leicht wiedergutzumachender Nachteil bei der Gruppe anfällt und damit wenigstens indirekt auch bei der formellen Inhaberin des Schutzrechts. Inwiefern dies in der vorliegenden Konstellation nicht der Fall sein sollte, ist nicht ersichtlich.
As noted above, defendant has apparently already appealed the decision.
Defendant’s appeal has been dismissed by the Supreme Court with decision 4A_575/2018 of 12 March 2019; published today.
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A big congratulations to Charlie Woodward from Allons, TN who is our 2018 Raffle winner! You are now the proud owner of a Beautiful 1936 knucklehead! We want to thank everyone involved who made this our best raffle year to date, we could never do this with out you!
The 2019 Wheels Through Time Raffle Bike is a stunning 1936 Harley-Davidson EL Knucklehead Bobber, painstakingly rebuilt in the WTT Restoration shop by museum founder and curator Dale Walksler and his team. The bike features a first year 61 c.i. OHV engine based around a genuine pair of new old stock replacement knucklehead engine cases mated to a 4-speed transmission in Harley-Davidson’s classic black and vermilion red with gold striping. This marks the second year in a row that Wheels Through Time will be raffling off the Holy-Grail of all American motorcycles. Many of the motorcycle industry’s top vendors collaborated with their parts, service, and expertise.
The raffle takes place in front of a live audience on Saturday, Nov 9th, 2019 at the Wheels Through Time Museum in Maggie Valley, NC. Second prize is $10k, and 3rd prize is $5k — you do not have to be present to win.
We wish you the greatest luck in the Wheels Through Time Annual Motorcycle Raffle!
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The Wheels Through Time Museum holds an annual raffle to help sustain the cost of operating the museum, and to build onto what is considered the best collection of All-American motorcycles in the world. Our mission is to preserve and share the culture, history, and artifacts of early American motorcycle history. Currently the museum houses over 300 machines, 10 cars, countless pieces of memorabilia, and over 15 timeless exhibits. For official Raffle Rules and Regulations, click the link below.
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§ 5.0 GRAND PRIZE: The Grand Prize is a 1936 Harley-Davidson Knucklehead. The winner of the Grand Prize also has the right to chose an alternate cash prize of $25,000. The winner will be contacted by telephone, e-mail and/or USPS mail as to his or her winnings immediately following the drawing. Winners will also be announced via the WTT website, and broadcasted live via FaceBook. 5.1 SECOND PRIZE: The Second Prize is a cash prize of $10,000. 5.2 THIRD PRIZE: The Third Prize is a cash prize of $5,000.
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If you have additional questions about the Wheels Through Time Raffle, you can email support@wheelsthroughtime.com and we will get back to you right away!

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The United States of America and Walter J. Vivenzio ("defendant") hereby enter into the following Plea Agreement ("Agreement") pursuant to Rule 11(c)(1)(B) of the Federal Rules of Criminal Procedure ("Fed. R. Crim. P.").
2. Defendant waives the rights set out in Paragraph 1(b)-(g) above. Further, pursuant to Fed. R. Crim. P. 7(b), defendant will waive indictment and plead guilty at arraignment to a two-count Information, in the form attached, to be filed in the United States District Court for the Northern District of New York. The Information will charge defendant with one count of violating 15 U.S.C. §1 in connection with a conspiracy to rig bids for and allocate roofing contracts awarded by the Waterford, New York plant of the General Electric Company ("GE Waterford"), the Albany Medical Center ("AMC") and other purchasers of roofing products and services in the State of New York from sometime in 1995 until approximately May 2002 and one count of violating 18 U.S.C. §371 in connection with a conspiracy to defraud GE Waterford through the use of the United States mails from sometime in 1995 until approximately May 2002.
3. Defendant, pursuant to the terms of this Agreement, will plead guilty to the criminal charges described in Paragraph 2 above and will make a factual admission of guilt to the Court in accordance with Fed. R. Crim. P. 11.
Third, that the activities of the defendant and co-conspirators were within the flow of and substantially affected interstate trade and commerce.
at least one of the overt acts charged in the Information to further some objective of the conspiracy.
consenting to adjournments of sentencing pending the completion of his cooperation, as determined to be necessary by the attorneys of the United States.
7. In order to facilitate the collection of financial obligations to be imposed in connection with this prosecution, defendant agrees to fully disclose all assets in which he has any interest or over which defendant exercises control, directly or indirectly, including those held by a spouse, nominee or other third party. Defendant will promptly submit a completed financial statement to the attorneys of the United States. Defendant promises that his financial statement and disclosures will be complete, accurate and truthful.
8. Defendant will not commit any further crime whatsoever, nor will he violate any condition of release or supervision imposed by the Court.
9. Subject to the full, truthful, and continuing cooperation of defendant, as described in Paragraphs 6 and 7 of this Agreement, the United States will not bring further criminal charges against him under 15 U.S.C. §1 or 18 U.S.C. §§371, 1341, 1343, 1346 (insofar as those statutes relate to mail fraud or to a conspiracy to commit mail fraud) for any act or offense committed before the date of this Agreement, in connection with a conspiracy to rig bids for or allocate roofing contracts in the State of New York. The nonprosecution terms of this paragraph do not apply to civil matters of any kind, to any violation of the federal tax or securities laws, or to any "crime of violence" as defined by U.S.S.G. § 4B1.2(a).
a term of supervised release of not more than one (1) year following any term of imprisonment. (18 U.S.C. § 3583(b)(3) and United States Sentencing Guidelines ("U.S.S.G.") § 5D1.2(a)(3)).
pursuant to 18 U.S.C. § 3013(a)(2)(A) and U.S.S.G. § 5E1.3, the Court is required to order defendant to pay a $100.00 special assessment.
a term of supervised release of not more than three (3) years following any term of imprisonment. (18 U.S.C. § 3583(b)(2) and U.S.S.G. § 5D1.2(a)(2)).
14. Defendant understands that sentencing for the offenses charged in the attached Information will be conducted pursuant to the United States Sentencing Commission Guidelines Manual (Nov. 2001) ("U.S.S.G." or "Sentencing Guidelines").
Increase by 2 levels because defendant acted as an organizer/leader in the criminal activity, pursuant to U.S.S.G. § 3B1.1 (c).
Increase by 8 levels because the loss exceeded $ 70,000, pursuant to U.S.S.G. § 2B1.1(b)(1)(E).
17. The antitrust offense does not involve substantially the same harm as the fraud offense, nor is it of the same general type as the fraud offense. Therefore pursuant to U.S.S.G. § 3D1.2, the antitrust offense is not grouped with the fraud offense charged in Count Two.
18.The fraud offense, with an offense level of 14, is between one and four levels less serious than the antitrust group, and thus, pursuant to U.S.S.G. § 3D1.4(a), counts as one unit. Because there are 2 units, two offense levels are added to the antitrust group offense level, yielding a combined offense level of 17.
19. Defendant has demonstrated a recognition and affirmative acceptance of responsibility for his criminal conduct, thereby reducing the adjusted offense level by three levels to level 14, pursuant to U.S.S.G. § 3E1.1(a)-(b).
20. The United States and defendant stipulate and agree that no other upward or downward adjustments under U.S.S.G. § 2B1.1 or Chapter 3 of the Sentencing Guidelines ("Adjustments") apply in determining defendant's offense level under the Sentencing Guidelines.
21. The United States and defendant stipulate the volume of commerce affected by the antitrust conspiracy is $1,491,742.50. The antitrust fine range for defendant is $14,917.42 - $74,587.12 pursuant to U.S.S.G. § 2R1.1(c)(1). Defendant's base fine for the adjusted combined offense level is $4,000 - $40,000 pursuant to § 5E1.2(c)(3). Since the antitrust offense fine range is greater, defendant's fine range is $14,917.42 - $74,587.12 pursuant to U.S.S.G. § 5E1.2(b).
22. Defendant understands that the sentence to be imposed on him is within the sole discretion of the sentencing judge. The United States cannot and does not make any promises or representations as to what sentence defendant will receive. Defendant understands that, as provided in Fed. R. Crim. P. 11(c)(3)(B), if the Court does not impose a sentence consistent with the stipulations and recommendations in this Agreement, he nevertheless has no right to withdraw his guilty plea. However, the United States will inform the Court and the Probation Office of (a) this Agreement; (b) the nature and extent of defendant's activities with respect to this case and all other activities of defendant which the United States deems relevant to sentencing; and (c) the timeliness, nature, extent and significance of defendant's cooperation and his commitment to prospective cooperation with the United States. In so doing, the United States may use any information it deems relevant, including information provided by defendant both prior and subsequent to the signing of this Agreement. The United States reserves the right to make any statement to the Court or the Probation Office concerning the nature of the criminal violations charged in the attached Information, the participation of defendant therein, and any other facts or circumstances that it deems relevant. The United States also reserves the right to comment on or to correct any representation made by or on behalf of defendant, and to supply any other information that the Court may require. The United States and defendant are free to recommend or argue for any specific sentence to the Court.
23. If the United States determines that defendant has provided substantial assistance in any Federal Proceedings, and has otherwise fully complied with all of the terms of this Agreement, it will file a motion, pursuant to U.S.S.G. § 5K1.1, advising the sentencing judge of all relevant facts pertaining to that determination and requesting the Court to sentence defendant in light of the factors set forth in U.S.S.G. § 5K1.1(a)(1)-(5). Such a motion will permit the Court, in its discretion, to impose a sentence below the applicable Sentencing Guidelines range. The United States and defendant are free to recommend or argue for any specific sentence to the Court.
24. Defendant acknowledges that the decision whether he has provided substantial assistance in any investigations or prosecutions is within the sole discretion of the United States. It is understood that should the United States determine that defendant has not provided substantial assistance in any Federal Proceeding, such a determination will release the United States from any obligation to file a motion pursuant to U.S.S.G. § 5K1.1, but will not entitle defendant to withdraw his guilty pleas once they have been entered. Defendant further understands that whether or not the United States files a motion pursuant to U.S.S.G. § 5K1.1, the sentence to be imposed on him remains within the sole discretion of the sentencing judge.
25. Defendant has reviewed all legal and factual aspects of this case with his attorney and is fully satisfied with his attorney's legal representation. Defendant has thoroughly reviewed this Agreement with his attorney and has received satisfactory explanations from his attorney concerning each paragraph of this Agreement and alternatives available to defendant other than entering into this Agreement. After conferring with his attorney and considering all available alternatives, the defendant has made a knowing and voluntary decision to enter into this Agreement.
26. Defendant's decision to enter into this Agreement and to tender a plea of guilty is freely and voluntarily made and is not the result of force, threats, assurances, promises, or representations other than the representations contained in this Agreement. The United States has made no promises or representations to defendant as to whether the Court will accept or reject the recommendations contained within this Agreement.
27. Defendant agrees that, should the United States determine in good faith, during the period that any Federal Proceeding is pending, that defendant has failed to provide full and truthful cooperation, as described in Paragraphs 6 and 7 of this Agreement, or has otherwise violated any provision of this Agreement, the United States will notify defendant or his counsel in writing by personal or overnight delivery or facsimile transmission and may also notify his counsel by telephone of its intention to void any of its obligations under this Agreement (except its obligations under this paragraph), and defendant shall be subject to prosecution for any federal crime of which the United States has knowledge including, but not limited to, the substantive offenses relating to the investigation resulting in this Agreement. Defendant agrees that, in the event that the United States is released from its obligations under this Agreement and brings criminal charges against defendant for any Relevant Offense, the statute of limitations period for such offense will be tolled for the period between the date of the signing of this Agreement and six (6) months after the date the United States gave notice of its intent to void its obligations under this Agreement.
28. Defendant understands and agrees that in any further prosecution of him resulting from the release of the United States from its obligations under this Agreement based on defendant's violation of the Agreement, any documents, statements, information, testimony, or evidence provided by him to attorneys or agents of the United States, federal grand juries, or courts, and any leads derived therefrom, may be used against him in any such further prosecution. In addition, defendant unconditionally waives his right to challenge the use of such evidence in any such further prosecution, notwithstanding the protections of Fed. R. Evid. 410.
29. This Agreement constitutes the entire agreement between the United States and defendant concerning the disposition of the criminal charges in this case. The United States has made no other promises to or agreements with defendant. This Agreement cannot be modified except in a writing signed by the United States and defendant.
30. The undersigned attorneys for the United States have been authorized by the Attorney General of the United States to enter this Agreement on behalf of the United States.


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Herget v. Central National Bank & Trust Co.
United States v. Frankfort Distilleries, Inc.
Dow Chemical Co. v. Halliburton Oil Well Cementing Co.
Commissioner v. Court Holding Co.
United States v. Commodore Park, Inc.
Georgia v. Pennsylvania Railroad Co.
United States v. Willow River Power Co.
FTC v. A. E. Staley Mfg. Co.
United States v. Hancock Truck Lines, Inc.
Precision Instrument Mfg. Co. v. Automotive Co.

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Atelier Winkler serves as planner, consultant and supervising partner from the first ideas to the finished project.
To ensure the best result possible, it is essential to thoroughly research the basic parameters, to examine the best ideas together and to determine the economic solution for execution.
We support you during all stages of your project and protect your interests with authorities, consultants and craftsmen.
A well-founded on site training as a brick-layer apprentice prior to my studies in the field of architecture at two universities as well as over 20 years of experience, form the foundation of my work as an independent architect.
From classic structural design (residential and industrial) to shop fitting projects for luxury retail stores up to interior construction of restaurant projects, I was free to work on more than 450 projects in Germany and abroad.
Architecture office Atelier Winkler (Atelier = Studio) specialized in Retail Real Estate, Store Design and Brand Development for (fashion) brands as well as projects for private clients (new developments or refurbishments) of all kinds with a focus on sustainability.
Responsible architect for three Outlet Shopping Centres in Belgium and Germany. 400+ shop fitting projects for luxury fashion brands completed in budget and time. Extensions, refurbishments, hospitality projects and implementation of structural additions and alterations (mezzanine levels-steel structures).
Teaching position in the field of internationalisation for students of retail management, innovation management and strategic marketing with a focus on brand development, branded environments and the development of store design concepts.
Retail Lab - spatial planning and sourcing of material donations, such as lighitng, HVAC & air curtain for a university owned retail lab implemented on campus. This lab was extended into the adjacent class room throughout 2016 and computer aided retail software workstations will become part of this multifunctional educational environment.
Leader: Directed the U.S. branch of a Germany shop fitting company for individual shop fitting concepts and SIS Systems.
Manager: Responsible for HR, expanded from 14 to 18 employees in three month. Prepared and translated contracts for all employees who had worked without one before.
Relationship Builder: Initiated relations with two critically important manufacturing partners in an three-month period.
Problem Solver: Solved issues with the warehousing and distribution process. Supervised the development of a universal part numbering key for the new software based inventory control system.
Translator: Translated simultaneously between English and German for the owner during meetings. Efficiently and accurately translated contracts and legal documents.
Intimately involved in the design and prototyping process for two flagship stores in Berlin (Germany) and Irvine, CA (USA).
Significantly enhanced planning processes by establishing plan standards and their implementation into the workflow of the Project Managers.
Created layout templates in AutoCAD, defined documentation and archiving standards, introduced the addition of scanned imagery on the large format plans.
Developed global CI-guidelines for the company and all its branches.
Implemented critical design and engineering modifications for improved fixture and fittings performance during countless meetings with the client and engineering consultants.
Accomplished in record time (16 weeks from planning process including prototyping to finished installation), both projects have been deemed to be a huge success.
Planned, designed and supervised the execution of the trade show booths for international clients focusing on European trade shows.
Supervised the installation of the trade Show booth for large electronic corporations on CeBIT ’05 in Hanover, Germany, the world’s largest computer fair.
Supervised the installation of the booth for a large Broadcasting Company for MipTV ’05 in Cannes, France.
Bridged intercultural communication challenges for the client.
Refitting of a high end store for luggage, handbags, wallet etc. drafting, engineering and supervision of execution and documentation.
Participation in urban design contest.
Apprenticeship to become a certified bricklayer completed successfully in 1 1/4 years.
It is my firm conviction that sustainable construction does not have to contradict architecture with a pleasant design. Vice versa, architecture that is pleasing to the eye should not have to depend on an antiquated need for fossil fuels and ressources.
Atelier Winkler develops custom made solutions for you taking all aspects such as function, economic, ecological and aesthetic design into consideration.
BIM stands for Building Information Modeling (Building Data Modeling) and is a new planning methodology which was developed to simplify the collection and assembly of information. When founding my office, I immediately decided to apply this new method from day one and to only plan in 3D.
With existing buildings, the documentation is often incomplete and difficult to decipher for the tenant. This ultimately leads to an increase in operating costs.
With BIM, the owner of the property is able to understand the project at all times, even if one is not able to read plans, as one can virtually "walk" through the computer generated model prior to execution.
For existing structures, it is of course possible to create such a 3D model any time for further planning and operating activities.
Research of all basic information - thorough research of all existing documents and parameters for a seamless operation of the structural works and an economic operation. For existing structures, as three-dimensional model is being generated after the exact measurements of the building has been executed.
Digital Model - reconfigurations, refurbishments and revitalization measurements are planned with the digital model first. All participating parties, such as civil engineers or other specialist planners work on the same computer model at all times.
Operation - after completion of all works and hand over to the owner, the digital model is handes over to facility management. All daily, weekly, monthly and yearly maintenance works can be scheduled and connected to the digital model. It also acts as an archive for documentation during the entire life span of the building. All alpha numerical values, such as schedules or costs are connected to the model and can be read at all times. By utilizing the model, the current status of the building is constantly being documented and operating costs can be compared to the planned costs and the budget.
Should the (retail) property be offered on the market, the BIM model can be sold separately with the building. A completely digitally documented building is of a significantly higher value and creates a much higher return of investment, as any tenant can start their planning immediately without delay caused by missing exact measurements of the interior.
Of course, this methodology can be applied to any kind of project.
Please note that this text has been translated by its owner, so that one might get a first insight into this law and its application. If in doublt, only the German version of this text acts as the defining and legally binding statement. Please refer to the German part of the website for all legally binding information concerning this issue as needed.
We are commited to observe the legal regulations for data protection and are making all efforts to always consider the principles of data avoidance and data reduction to its minimum.
a) you have given us your explicit consent to process your personal data for one or several purpose/s, Art. 6 Abs. 1 S. 1 lit. a DSGVO. You are being informed explicitly about the purpose or purposes of the processing of your data in detail by us and your consent is being documented by us.
b) The processing of your personal data is needed to fulfill a contract or to execute measures leading up to a contract with you, Art. 6 Abs. 1 S. 1 lit. b DSGVO.
c) The processing of personal data is needed to secure our legitimate interest, insofar as your interests or fundamental rights and liberties outweigh our interests, Art. 6 Abs. 1 S. 1 lit. f DSGVO. We always indicate explicitly which legal regulation forms the basis of the processing of your personal data.
b) the transmission as outlined in Art. 6 Abs. 1 S. 1 lit. f DSGVO is needed to practice, exercise or defend legal rights and there is no reason to presume that you own a higher interest worth protecting, avoiding transmission of your data.
We save all personal data transmitted to us for as long as it is needed to fulfill the purpose they were sent for, only. Alternatively we save it for as long as it is required by law. Once the purpose has been fulfilled and/or the mandatory period has expired, the data will be deleted or blocked.
This website uses SSL-Encryption to secure confidential information that you have sent to us, i.e. requests you have sent to the web site provider, only. You can identify encrypted connections by the address changing from "http://" to "https://" in the browser address line and by the lock symbol next to it.
If the SSL-Encryption is enabled, data transmitted to us cannot be read by third parties.
When visiting our website, no data is being collected.
You are welcome to send us an e-mail to the address provided on our website. We store and process your e-mail as well as all information provided therein according to Art. 6 Abs. S. 1 lit. b and f DSGVO only. The e-mail and corresponding data will be deleted three months upon receipt latest, insofar they are not needed for another contractual relationship.
According to Art. 16 DSGVO you have the right for incorrect or uncomplete stored personal data we have, to be corrected.
• To fulfill a legal obligation, that requires the processing according to the right of the European Union or the Member State, the responsible underlies. Also legal obligations falling under a public interest or execution of public law, that the responsible has been transcribed to.
• the for the public interest lying interests for archiving purposes, scientific of historic research purposes or statistical purposes according to Art. 89 Abs.1 DSGVO insofar as it concerns the right named in a) supposedly prevents or significantly reduces its implementation.
• The processing is unlawful, and you oppose the right to delete the personal data.
• We no longer require the data for purposes of processing. You, however need it to enforce, execute or defend legal claims.
• You oppose processing of your data according to Art. 21 Abs. 1 DSGVO.
If you have demanded a correction or deletion of your personal data or have requested a limitation of processing according to Art. 16, Art. 17 Abs. 1 und Art. 18 DSGVO to be considered, we notify all recipients that have been given access to your personal data, unless this proves to be impossible or is only achievable by a disproportionate effort on our side. You are entitled to demand of us that we notify you about these recipients.
You remain the right, according to Art. 7 Abs. 3 DSGVO, to revoke your consent given at any given moment. By revoking the consent given before, the lawfulness of processing up to this cancellation, is not affected. Any data processing that was based on your revoked consent before may no longer be processed by us in the future.
As stipulated in Art. 77 DSGVO, you are entitled to appeal to a regulatory authority, should you believe that the processing of your personal data is not compliant with the DSGVO.
If your personal data is being processed due to legitimate interests according to Art. 6 Abs. 1 S. 1 lit. f DSGVO, you remain the right, according to Art. 21 DSGVO, to object to the processing of your personal data, insofar there are reasons given, which are derived from your situation or if the objection is aimed against direct advertising. In this last instance you have a general right to object, that will be complied with by us without the need to specify the situation as such. Should you wish to use this general right to appeal or object, an e-mail to info[at]atelier[minus]winkler[full stop]de is sufficient.
i. is needed for signature or fulfillment of a contract between you and us.
ii. due to legal obligations making it lawful in the European Union or the Member State we are underlying, and this legal obligation contains appropriate procedures to retain your rights of freedom and your legitimate interests therein.
Admittedly, these decisions are not to be based on specific categories of personal data according to Art. 9 Abs. 1 DSGVO, insofar as Art. 9 Abs. 2 lit. a or g DSGVO is not applicable and adequate measures have been taken to protect the rights and freedoms as well as your eligible interests.
Concerning cases i) and ii) we take appropriate measures to protect your rights and freedoms as well as your eligible interests, whereto the right to enforce the intervention of a person on our side, to declare one´s own point of view and on appealing the decision belongs to, as a minimum.
Should we alter the Data Protection Statement, we will indicate this on the website.
Awarded by the enrolment commission of the Bayerische Architektenkammer (Chamber of Bavarian Architects), Munich (State Bavaria, Germany) according to article 1 of Baukammerngesetz (BauKaGe). The Bayerische Architektenkammer is the designated regulating authority for all architects based in Bavaria.
Member of Bayerische Architektenkammer since 2012.
Should a project require a higher insurance cover, this can be arranged with an addendum to the above insurance on a project by project cover.
The rights for all images used are with the owner of the website and were either taken by himself or by the photographer Rolf Nachbar (Rolf Nachbar Fotografie und Design, Badstrasse 1, 97234 Reichenberg www.nachbar.de) and the rights were passed on when purchasing the imgages. In the case of the book covers, the rights were awarded by the publisher (MEC Metro ECE Centermanagement, Düsseldorf, Germany and Springer Verlag).
Atelier Winkler appreciates clients, project partners and co-workers with all national or cultural backgrounds, denominations, gender or sexual orientation, disability or age, income or political views. We build customized solutions for humans in all circumstances, and on eye level with all participating parties.
Atelier Winkler is located in the historic city centre of Würzburg´s pedestrian zone between Dom (Würzburg Cathedral) and Alte Mainbrücke (Old Main Bridge Würzburg).
It can be reached easily by tram (stations Dom or Rathaus) from Würzburg´s main train station.
Underground parking is available in the parking decks "Wöhrl" located in Oberer Mainkai and "Marktgarage" located in Karmelitenstrasse in walking distance from the office.

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Art. 6
Art. 21
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United States Court of Appeals, Tenth CircuitNov 12, 2004. Full title ... See O Centro Espirita v. Ashcroft, 314 F.3d ..... As the Supreme Court observed in Wygant v. Jackson Bd. of ...... States v. Garrido-Santana, 360 F.3d 565, 576-77 ( 6th Cir.
Apr 29, 1999 ... Jones v. United States, 357 U.S. 493, 499 (1958). 10. Exceptions to the warrant requirement include, inter alia, searches incident ...... 476 U.S. 747, 796 n.5 ( 1986) (White, J., dissenting); Wygant v. ...... Santana, 427 U.S. 38, 43.
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Mar 29, 2018 ... Irving E. Vega,a,b,* Laura Y. Cabrera,a,c Cassandra M. Wygant,a Daniel Velez- Ortiz,d .... Olarte L, Schupf N, Lee JH, Tang MX, Santana V, Williamson J, ... of Alzheimer's disease mortality: United States versus Puerto Rico.

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The OSSBA has prepared an election packet (click here to download a Microsoft Word version) to aid your district with preparations for the annual school election or a special election. For your convenience, we also have a candidate information brochure and elections and campaigns guidance available.
When must a candidate file for the school board election?
When are the school board elections?
When would a runoff election be required?
Who is eligible/ineligible to file for the school board election?
Who are “second degree” relatives?
Who can contest a candidacy?
How does someone contest a candidacy?
What are valid reasons to contest a candidacy?
What if no one files for a board seat?
What if only one person files for the seat, does the incumbent immediately turn possession of the seat over to the new person?
If a new person will be taking the board seat, when does the current school board member’s term end?
How does a new school board member take the oath of office?
How long will a current board member (whose term is ending) serve if he/she does not intend to run again or loses the election?
Candidates can file from Monday, Dec. 3 through Wednesday, Dec. 5, 2018. 26 O.S. § 13A-105. Keep in mind that filings must take place before the close of business at the county election board.
The school board general election is April 2, 2019. If more than two candidates file, a school board primary election will be Tuesday, Feb. 12, 2018. If no candidate receives more than 50 percent of the vote, the top two candidates will proceed to the school board general election on Tuesday, April 2, 2019. 26 O.S. § 13A-103.
To be eligible to be a candidate for member of the board of education of a school district, a person must have resided in the district for at least six months preceding the first day of the filing period, and have been a registered voter registered with the county election board at an address located within the geographical boundaries of the district for six months preceding the first day of the filing period. In school districts that have been divided into election districts, a candidate must have resided in the district for six months preceding the first day of the filing period and have been a registered voter registered within the county election board at an address located within the geographical boundaries of the election district for six months preceding the first day of the filing period. 26 O.S. § 13A-106.
No person shall be eligible to be a candidate for or elected to be a member of the board of education of a school district unless the person has been awarded a high school diploma or certificate of high school equivalency. 26 O.S. § 13A-106.
A person who has been convicted of a misdemeanor involving embezzlement or a felony under the laws of this state or of the United States or who has entered a plea of guilty or nolo contendere to such misdemeanor involving embezzlement or felony or who has been convicted of a crime in another state which would have been a misdemeanor involving embezzlement or a felony under the laws of this state or has entered a plea of guilty or nolo contendere to such crime shall not be eligible to be a candidate for or be elected to any state, municipal, judicial, or school office or any other elective office of any political subdivision of this state for a period of fifteen years following completion of his sentence or during the pendency of an appeal of such conviction or plea.
The candidate is ineligible to run if he or she is an incumbent who has failed to earn his or her continuing education credits for the current term of office. 70 O.S. § 5-110.1, O.S.L. § 58 & AG Op. No. 01-33.
No candidate shall be eligible to be a candidate for or serve on a board of education if he or she is currently employed by the school district governed by that board of education or is related within the second degree by affinity or consanguinity to any other member of the board of education or to any employee of the school district governed by the board of education. 70 O.S. § 5-113. Another exception applies for districts with an average daily membership of less than 400. A candidate for school board may be related by blood or marriage to a current district employee, if the district has an average daily membership of less than 400 and has adopted a policy permitting the exception pursuant to 70 O.S. §§ 5-113, 5-113.1 (effective April 23, 2018). Second-degree relatives may be employed as substitute teachers or as temporary substitute support employees if ADM is less than 5,000.
Siblings of “half-blood,” meaning that two individuals share one parent, are considered equal to a full sibling sharing two parents.
Any candidate for the same office may contest the other person’s candidacy. If the candidate is running unopposed, any voter who is eligible to vote for the candidate may contest the candidacy. 26 O.S. § 5-118, O.S.L. § 713.1.
A petition (to contest candidacy) must be filed by 5:00 p.m. on the second day following the close of the filing period. The petition must allege that the candidate was not qualified by law to be a candidate and must contain the reasons why the candidate was not qualified. Any reasons which do not appear on the face of the petition are deemed waived and cannot later be added.
The petition is to be filed with the Secretary of the County Election Board who accepted the declaration of candidacy. The contesting of candidacy requires a $250 deposit.
Upon the filing of a petition, the secretary of the appropriate election board must set the matter for a hearing. The hearing cannot be held fewer than three (3) days from the filing of the petition.
It is the obligation of the petitioner to have the candidate served with a copy of the petition. The service must be made in person, where possible, within twenty-four (24) hours after the date and place of the hearing has been set by the county election board secretary. Service must be made by the Sheriff of the county of residence of the individual whose candidacy is being contested.
The petition may be heard without formal pleadings being filed in answer or reply to the contesting petition. The election board may serve subpoenas and compel the attendance of witnesses and production of evidence. At the conclusion of the hearing, the board shall render its decision and the vote of the individual members in writing. The decision of the board shall be final.
If the board determines that the candidate was not qualified, it may order the candidacy stricken and the individual’s name shall not be placed on the ballot. If possible, the board may order the candidate to amend the declaration of candidacy to conform with law.
Should the candidate whose candidacy is being challenged desire to appear in answer to the contest, the candidate is required to deposit with the secretary of the election board a cashier’s check or certified check in the same amount as that filed by the petitioner.
The burden of proof remains on the petitioner to sustain the allegations in the petition. Failure of the candidate to appear or answer shall be deemed default and shall constitute an admission.
In the event the petitioner is successful, his deposit shall be returned to him and all costs of the hearing shall be deducted from the deposit of the candidate whose candidacy was contested. If the candidate does not appear or answer the costs shall be deducted from the deposit made by the petitioner and the balance, if any, shall be returned to the petitioner.
26 O.S. §5-118, et seq.
Candidate does not live in the district.
Candidate is a district teacher’s brother.
Candidate has no continuing education credits earned during her first 5 year term.
Candidate was convicted of a felony 3 years ago.
Candidate does not have a high school diploma or equivalent.
Candidate is not registered to vote in this district.
If no one files for the open board seat, the seat is officially vacant as of the date of the election. The board of education would have 60 days from the date of the election to appoint an individual to the vacant seat or the board would have to call a special election to fill the vacancy. Any person appointed would have to meet all eligibility requirements as if they had run for office.
Even if only one person files for a seat, the candidate is ineligible to take office until the date of the election passes and the election results are certified. Because the official election takes place on Tuesday, April 2, election results should be certified by Friday, April 5, 2019. Absent a race, the election results could be certified as early as December of 2018. However, the certification alone does not end the previous person’s term of office. The original term of office runs through the April election date. Thus, the “new” board member is seated at the first meeting following the April election date.
The current school board member will continue serving until the date of the election passes and the election results are certified.
The oath can be found at 70 O.S. §5-116. This oath can be taken at a board meeting after the board member is certified by the county election board. The method by which the oath is taken can vary. The new board member can read aloud the oath, or the board can utilize a “repeat after me” format. The oath can also be taken before a notary public.
The current board members continue to serve until the election passes and election results are certified by the county election board.