NEW ACCOUNT REGISTRATION FORM

ACCOUNT INFORMATION

PRACTICE PROVIDERS AND/OR FACILITY INFORMATION

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SIGNATURES

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FULFILLMENT AGREEMENT

This Fulfillment Agreement (the “Agreement”) is entered into as of this day (the “Effective Date”) between ADVANCED WOUND SUPPLY, LLC, a Florida limited liability company and You, (the Customer).

Background
The Provider wishes to purchase, and ADVANCED WOUND SUPPLY, LLC (“ADVANCED WOUND”) has agreed to sell to Provider human cell and tissue products, subject to the following terms. Herein the "Customer" shall be referred to as the (“Provider”). ADVANCED WOUND SUPPLY, LLC is considered to be the Distributor to the Doctor / Provider. Now, therefore, the parties agree as follows:

1. Product Prices. Product means the human cell and tissue products offered by ADVANCED WOUND as described in Schedule A, as such Schedule may be modified from time to time. The “Cost” for each Product is the price to the Provider from ADVANCED WOUND stated for that Product in Schedule A.


2. Insurance Verification / Order Fulfillment. Provider is responsible for all billing, coding, and other claims processes. ADVANCED WOUND shall not be held responsible for any claim liabilities by the Doctor / Provider. After Provider submits an IVR and receives confirmation of patient’s benefits at their own risk, the Provider places an order, via email, through ADVANCED WOUND. The Distributor will have accepted the order and will generate an Order Statement. This statement will reflect that the Provider has agreed to purchase the Products identified on the Statement and the terms of the purchase. The Distributor shall, on Provider’s behalf, place the order request to the Manufacturer and the Manufacturer shall place and pack the Products identified on the Statement for delivery to the Provider using second-day delivery. The Distributor shall provide delivery status information from the carrier to the Provider for shipment. Provider shall make all payments directly to ADVANCED WOUND. Nothing contained in any order from Provider shall in any way modify such terms of Distributor or add any additional terms or conditions. No order shall be binding upon Distributor until accepted in writing by Distributor and Distributor shall have no liability to Provider with respect to orders that are not accepted. No partial shipment of an order shall constitute the acceptance of the entire order, absent the written acceptance of such an entire order. All Products delivered pursuant to the terms of this Agreement shall be suitably packed for shipment in Distributor’s standard shipping cartons, marked for shipment by Distributor’s or its partners to End-User’s address and directly delivered to End- User. The End-User is responsible for any freight, insurance, and other shipping expenses. Shipping dates are approximate and are based upon prompt receipt of all necessary information from Provider. Distributor shall use commercially reasonable efforts to deliver Products at the times specified in the order. It is the Provider’s responsibility to keep track of and communicate all product tracking numbers back to Distributor once implanted.


3. Product Usage. After receiving Product(s), Provider will treat the patient as medically necessary. Provider and ADVANCED WOUND acknowledge that use of any Product is at the sole discretion of the treating provider, pursuant to his or her professional medical judgement. Provider will timely provide Distributor, upon request, copies of documents issued or received in connection with obtaining, maintaining or complying with the applicable regulatory and other governmental approvals required to market the Product for Distributor’s review. Provider will maintain records which identify all purchasers or End-Users of the Product, including but not limited to the name, address and telephone number of the purchaser, the type and quantity of the Product sold to such purchaser, the date the Product was sold, the lot number of the Product sold, and the amount billed and received from such purchaser. All such records shall be retained for the longer of 10 years beyond the date of (a) distribution; (b) transplantation (if known); or (c) disposition; or (d) expiration of the tissue, or such longer period, as may be required by applicable Laws. Records shall be maintained in a manner to preserve their completeness and accuracy over time and shall be accessible to Distributor, in a timely manner, upon an Adverse Event or recall order. Provider shall notify and send Distributor all such records if Provider is closing, dissolving, transferring, or selling its business. This provision shall survive termination of this Agreement. Provider agrees all marketing information of Distributor’s Products must be reviewed and pre-approved by Distributor in writing prior to being submitted to any potential End-User. Provider shall not promote the Products for any uses not pre-approved for such Products by applicable regulatory authorities or Distributor. Provider shall provide to Distributor for purposes of review and comment by Distributor any and all promotional, advertising, and educational materials and programs relating to the Products at least thirty (30) days prior to the release of such materials or commencement of such programs. Provider agrees that Distributor owns all rights and interest in the product lines that include the Products and in all of Distributor’s patents, trademarks, trade names, inventions, copyrights, know-how, and trade secrets relating to the design or processing of the Products, selling materials, product sheets, selling strategies, selling techniques, marketing materials, samples, coding information, etc. The use by Provider of any of these property rights is authorized only for the purposes herein set forth, and upon termination of this Agreement, for any reason, such authorization shall cease. All materials and samples shared with Provider during the Term of this Agreement or at anytime prior or afterwards shall be returned to Distributor promptly at either the time of termination of this Agreement or at when requested by Distributor. Provider will have access to certain confidential information and materials concerning Distributor’s Products, including but not limited to Distributor’s business formation and operations, future plans and goals, pricing information, manufacturer’s names and how the Products are manufactured, payment processing information, marketing presentations, marketing materials, potential and actual End-User names and contact information, End-User purchase frequency and amounts paid by End-Users, Distributor’s technology, and Product implantation methods (“Confidential Information”). The Confidential Information is of substantial value to Distributor and constitutes Distributor’s trade secrets, which value would be impaired if such Confidential Information were disclosed to third parties. The Provider covenants and agrees that Provider shall not, during the Term of this Agreement, except in the performance of obligations hereunder, or for a period of five (5) years after termination of this Agreement, communicate or disclose to any third party (other than Distributor, the Distributor’s agents, consultants, auditors or attorneys) any Confidential Information which was obtained or acquired by the Provider during the Term of this Agreement. The Provider shall defend, indemnify and hold harmless Distributor, its officers, directors, members, employees and agents from and against any loss, liability, claim or damage (including reasonable attorneys’ fees and costs) relating to or arising from (i) any claim or allegation in connection with the promotion of Products by the Provider; (ii) a breach of this Agreement by the Provider; and (iii) any negligent acts or negligent representations by Provider.


4. Product Cost. The pricing the Provider shall pay for each skin graft is shown on the Product Cost column of Schedule A. The invoice total shall be based on the price of all Products used for that month. Provider agrees to fully and accurately report all amounts paid hereunder to Medicare, Medicaid and all other federal and state health care programs and third-party payers if required by the discount safe harbor to the anti-kickback statute, 42 CFR 1001.952(h), and other applicable laws or agreements, and to provide copies of this Agreement and all other applicable information provided by ADVANCED WOUND related to this Agreement and the amounts paid hereunder to Representatives of these programs and other third-party payers upon their request.


5. Invoices & Payment. Upon shipment of the product, ADVANCED WOUND will develop and deliver an Invoice to Provider that identifies the Products ordered and the Provider’s outstanding balance, which shall reflect the Invoice Price of the Products ordered and not yet paid by the Provider. Provider agrees to pay ADVANCED WOUND the balance due amount stated in each Invoice within thirty (30) days from the date of product placement. The product is considered placed on the day the Provider sends an email requesting the product. If your account is not paid in full within six (6) days after a monthly payment is due, a late charge payment may be assessed on the outstanding balance of 1.5% per month, or 18% per year, (simple interest) or to the maximum extent permitted by State law, until paid. Provider agrees to fully and accurately report all amounts paid hereunder to Medicare, Medicaid and all other federal and state health care programs and third-party payers if required by the discount safe harbor to the anti-kickback statute, 42 CFR 1001.952(h), and other applicable laws or agreements, and to provide copies of this Agreement and all other applicable information provided by ADVANCED WOUND related to this Agreement and the amounts paid hereunder to Providers of these programs and other third-party payers upon their request. Any terms relating to Products and services offered by Distributor shall be determined solely by Distributor.


6. Non-Disclosure. Definition - "Confidential Information" means any information, technical data, or know-how, whether or not it is patented, copyrighted or trademarked, including, but not limited to, that which relates to research, data, algorithms, formulae, product plans, prototypes, products, services, customers, markets, software, developments, inventions, processes, designs, drawings, engineering, hardware configuration information, marketing or finances, whether or not such Confidential Information is designated in writing to be confidential or proprietary. Confidential Information does not include information, technical data or know- how that (i) is in the possession of the Recipient at the time of disclosure as shown by the Recipient’s files and records, or (ii) becomes part of the public knowledge or literature, not as a result of any breach of this Agreement by the Recipient, or (iii) is provided to the Recipient on a non-confidential basis by a third party, or (iv) is approved by the Disclosing Party, in writing, for release; or (v) is independently developed by the Recipient without reference to the Confidential Information as evidenced by records contemporaneously maintained. Without limiting the generality of the foregoing, Confidential Information includes any reports or documents created by the Recipient that include, summarize or refer to the Disclosing Party's Confidential Information disclosed hereunder. Nondisclosure and Non-Use of Confidential Information.
   
   Recipient agrees that it will not, and it will not permit any of its employees, agents or representatives to, (a) use any Confidential Information disclosed to it by the Disclosing Party for its own use or for any purpose except to carry out discussions concerning, and the undertaking of, any business relationship between the two parties, (b) copy, recreate or otherwise reproduce any Confidential Information in whole or in part, except as necessary to use such Confidential Information for purposes expressly permitted by this Agreement, or (c) disclose any Confidential Information of the Disclosing Party to third parties or to employees of Recipient except employees who are required to have the information in order to carry out the discussions of the contemplated business and will promptly notify the Disclosing Party in writing of the names of each such employee upon the request of the Disclosing Party at any time. Recipient will have or has had employees to whom Confidential Information of the Disclosing Party is disclosed, or who have access to Confidential Information of the Disclosing Party, sign a nondisclosure agreement in content substantially similar to this Agreement. Recipient agrees that it will protect the secrecy of and avoid disclosure or use of Confidential Information of the Disclosing Party in order to prevent it from falling into the public domain or the possession of persons other than those persons authorized hereunder to have any such information. Recipient shall also treat the Confidential Information with the highest degree of care that Recipient utilizes to protect its own Confidential Information of a similar nature. Recipient agrees to notify the Disclosing Party in writing of any misuse or misappropriation of Confidential Information of the Disclosing Party that may come to Recipient's attention.


7. Compliance. Provider will perform Product promotion and transfer activities in compliance with the American Association of Tissue Banks (“AATB”) Standards (https://www.aatb.org/standards) and regulations set forth by the United States Food and Drug Administration (“FDA”) and/or applicable state or federal laws or regulations. It is explicitly understood by the Parties that the buying and selling of human tissue is prohibited by federal and state law and any fees associated with the provision of human tissue are related to the cost of recovery, processing, promotion and related operating costs of providing human tissue for implantation. Distributor will have the right to review any materials, or letters, which make any claims of safety or efficacy of the Products.
   
   Compliance with Laws and Regulations. Provider shall comply fully, at its expense, with any and all applicable laws and regulations, whether federal, state or self-governing entity (such as FDA and AATB), applicable to the marketing and promotion of the Products. Provider shall, at its own expense, exercise due diligence to promptly obtain and maintain any necessary government or self-governing entity approvals or permits in each jurisdiction in the Territory. Provider shall use its best efforts to promote the Products for use only by qualified End-Users and for uses and applications pre- approved by Distributor for the Products.
   
   In order to comply with applicable law and to protect Distributor from claims and liabilities, Provider’s and its own Provider’s communications and representations to Distributor’s customers shall be true, accurate, complete and consistent with the labeling of Products. Provider and its Providers shall in no circumstances modify, repackage, adulterate, misbrand, alter or add labels to or remove labels from any Products, included related instrumentation and accessories. Provider may not make any alteration in the Products, packaging or package inserts, nor deface, remove, cover up or mutilate, in any manner whatsoever, any Distributor’s Trademark (as defined in Section 9.1 below), serial number, model number, or other information which Distributor may attach or affix to the Product, packaging or package inserts, nor may the Provider add its own trademark, service mark or brand thereto, without the prior written consent of Distributor. Provider will not engage in the practice of direct billing of Products or services to any third party whatsoever.
   
   Provider shall: (i) comply with all compliance and regulatory program(s), including any and all required training related to the applicable federal and state statutes; (ii) comply with all rules and procedures as may be required from time to time by Distributor; and
   
   Fully cooperate with and meet with Distributor, manufacturer or its designee to assure such compliance.
   
   Provider agrees to conduct Provider’s business in compliance with all applicable laws, regulations, and policies pertaining to the marketing and sale of Products applicable to the marketing and sale of medical products, devices and equipment to healthcare providers including, but not limited to, the anti-kickback statute of the Social Security Act, Section 1128B(b)(1) and (2), 42 U.S.C. Section 1320A- f(b)(1) and (2), the Physician Payments Sunshine Act, and the AdvaMed Code of Ethics. Provider further acknowledges that Provider may be receiving and processing Protected Health Information (“PHI”), as that term is defined in 45 C.F.R. Section 164.501, from Distributor or any third party. Provider shall collect, hold, use and disclose such information only for the purposes authorized, in accordance with any and all applicable data privacy laws and as expressly directed by Distributor. Provider shall not disclose any PHI to any third party or use PHI for any purpose, commercial or otherwise. Provider shall either (i) remove any PHI from its records and/or systems no later than necessary for the treatment of the patient at issue after receipt of such PHI or (ii) take reasonable measures to ensure the security and confidentiality of such PHI.
   
   Provider shall: (i) comply with the requirements of Distributor and Manufacturer’s then-current Code of Conduct; US Fraud & Abuse Compliance Policy; and other policies and procedures (collectively “Company Policies”) as may be amended from time to time; (ii) indemnify Distributor and any of its sister corporations, holding corporations or individual principal officers (“Affiliates”) for any damages (including attorney’s fees and costs) Distributor incurs or suffers due to a violation of Company Policies; (iii) cooperate in any Distributor (and any of its Affiliates) investigation relating to sales Provider activities including, but not limited to, investigations relating to any allegations of fraud or abuse; and (iv) cooperate with Distributor (and any of its Affiliates) with respect to any reporting or similar requirement.
   
   Provider shall: (i) comply with all compliance and regulatory program(s), including any and all required training related to the applicable federal and state statutes; (ii) comply with all rules and procedures as may be required form time to time by Distributor; and
   
   Fully cooperate with and meet with Manufacturer, Distributor or its designee to assure such compliance.
   
   To ensure Distributor’s compliance with applicable statutes and regulations, Provider agrees that Provider shall not solicit, engage, compensate or remunerate a potential End-User, or otherwise to induce any health care provider to purchase Products as consideration for becoming a consultant to or for Distributor or any Affiliate of Distributor or otherwise.
   
   Provider represents and warrants that Provider is not currently excluded, debarred, suspended, or otherwise ineligible to participate in the federal or state health care programs or in federal or state procurement or non-procurement programs, and Provider further represents and warrants that Provider’s employees, Sub-reps, or other personnel, agents, subsidiaries and affiliated entities are not currently excluded, debarred, suspended, or otherwise ineligible to participate in the federal or state health care programs or in federal or state procurement or non-procurement programs. Provider agrees to notify Distributor within ten (10) days in the event of any initiation of any investigation or action regarding Provider’s or Sub-rep’s activities including any action to debar, or exclude, final adverse action, or discovery of employment of or contract with an excluded or debarred individual or entity.
   
   Provider represents and warrants that Provider shall immediately notify Distributor if Provider, or any of Provider’s employees, employees, contractors, subsidiaries or affiliated entities, becomes excluded, debarred, suspended, or otherwise ineligible to participate in the federal or state health care programs or in federal or state procurement or non-procurement programs during the term of this Agreement. Further, at least every twelve (12) months, Provider shall, check its Sub-reps, sales associates, employees, and contractors against the (i) OIG Exclusion List (exclusions.oig.hhs.gov); (ii) FDA debarment list (www.fda.gov/ora/compliance_ref/debar/); and otherwise not excluded from contracting with the federal government (see the Excluded Parties Listing System at epls.arnet.gov).
   
   Provider agrees to fully cooperate with Distributor and manufacturer with respect to any reporting requirements, investigation or similar proceeding. At the request of Distributor, Provider shall, among other things, make itself available for interview(s) with Distributor and/or provide documents or other material as requested by Distributor. This obligation shall survive termination of this Agreement regardless of cause.


8. W9. Provider shall submit W9 and all necessary documents to Distributor prior to first commissions being paid.


9. Indemnification. The Provider shall defend, indemnify and hold harmless ADVANCED WOUND and the Manufacturer, its officers, directors, members, employees and agents from and against any loss, liability, claim or damage (including reasonable attorneys’ fees and costs) relating to or arising from (i) any claim or allegation in connection with the billing of the Product by Provider (ii) a breach of this Agreement by the Provider; and (iii) any negligent acts or negligent representations by Provider (iii) Medicare takebacks (iv) any losses pertaining to Provider’s direct implementation of the product.


10. Insurance. During the term of this Agreement the Provider shall obtain and maintain, at its sole cost and expense, General Liability insurance and Errors and Omission insurance policies with a minimum of $1,000,000 coverage benefit.


11. Governing Law and Jurisdiction. This Agreement shall be governed by, and construed and interpreted in accordance with, the laws of the State of Florida. The federal and state courts located within the State of Florida shall have exclusive jurisdiction to adjudicate any dispute arising out of this Agreement. Provider hereby expressly consents to (i) the personal jurisdiction of the federal and state courts within Florida, (ii) service of process being effected upon Provider by registered mail sent to the address set forth at the beginning of this Agreement, and (iii) the uncontested enforcement of a final judgment from such court in any other jurisdiction wherein Provider or any of Provider’s assets are present.


12. Legal Expense. The prevailing party shall be entitled to recovery of all reasonable attorneys’ fees and costs for any legal action brought by one party against the other which arises out of any claims relating to or for breach of this Agreement.


13. Miscellaneous. This Agreement contains the entire agreement between the Parties concerning the subject matter hereof and is governed by Florida law. Provider may only amend this agreement if agreed upon in writing by ADVANCED WOUND. Schedule A shall be given to Provider after execution of this Agreement, and shall be considered a binding part of this contract. Distributor reserves the right to interpret, modify, or supplement the provisions of this handbook at any time. Distributor may, from time to time, amend or modify the terms and/or conditions of this Agreement, the General Terms and Conditions, the exhibits attached hereto and/or the terms and/or conditions , etc. Amendments and modifications to this Agreement will be considered given and effective on that given date. It is the Provider’s obligation to ensure that they regularly coordinate with Distributor to review all modifications and amendments. In the event of a conflict between (i) this Agreement and (ii) an exhibit or amendment, the exhibit or amendment shall control.


14. Previous Agreements. This Agreement supersedes and replaces all previous oral or written agreements, memoranda, correspondence or other communications between the parties hereto relating to the subject matter hereof.

Executed as of the Effective Date.

BUSINESS ASSOCIATE AGREEMENT

This BUSINESS ASSOCIATE AGREEMENT is entered into this day (Effective Date) by and between the Provider/Practice, a professional corporation, limited liability company (“Covered Entity”) and ADVANCED WOUND SUPPLY, LLC, a Florida limited liability company (“Business Associate“) for the purpose of setting forth the terms and conditions on which Business Associate will provide services, as defined herein, on behalf of Covered Entity (“Agreement”).

WHEREAS, Covered Entity is subject to the federal Health insurance Portability and Accountability Act of 1996, 42 U.S.C. 1320d - 13206-8 (“HIPAA”), as amended from time to time, and is required to safeguard individually identifiable health information the Covered Entity creates, receives, maintains or transmits (hereinafter “protected health information" or "PHI") in accordance with the requirements HIPAA establishes and also the requirements set forth in the Health Information Technology for Economic and Clinical Health Act and any regulations promulgated there under (the “HITECH Act”);

WHEREAS, Covered Entity desires to engage Business Associate, whereby Business Associate will sell and provide human cell and tissue products to the Covered Entity that may involve the use or disclosure of PHI created, received, maintained or transmitted by Covered Entity and/or other Business Associates of Covered Entity; and

WHEREAS, Business Associate desires to perform the designated services on behalf of Covered Entity.

NOW THEREFORE, for and in consideration of the mutual premises, conditions and covenants herein contained, the parties hereto agree as follows:

1. DEFINITIONS
   The following terms used in this Agreement shall have the same meaning as those terms in the HIPAA Rules: Breach, Data Aggregation, Designated Record Set, Disclosure, Health Care Operations, Individual, Minimum Necessary, Notice of Privacy Practices, Protected Health Information, Required by Law, Secretary, Security Incident, Subcontractor, Unsecured Protected Health Information, and Use. Other capitalized terms shall have the meaning ascribed to them in the context in which they first appear.
   
   a. Regulations. Terms used, but not otherwise defined, in the Agreement shall have the same meaning as those terms in the federal Standards for Privacy of Individually Identifiable Health Information, 45 C.F.R. Part 160, subpart A and Part 164, subparts A and E (the “Privacy Rule"); the federal Security Standards, 45 C.F.R. Part 160, subpart A and Part 164, subparts A and C (the “Security Standards"); and 45 C.F.R. Part 160, subpart A and Part 164, subpart D (the “Breach Notification Rule"), and as each may be amended from time to time. Collectively, the Privacy, Security and Breach Notification Rules are referred to as the "HIPAA Rules.
   
   b. Business Associate. “Business Associate” shall generally have the same meaning as the term "Business Associate" at 45 CFR 160.103, and in reference to the party to this Agreement, “ADVANCED WOUND SUPPLY”.
   
   c. Covered Entity. “Covered Entity" shall generally have the same meaning as the term “covered entity” at 45 CFR 160.103, and in reference to the party to this Agreement, shall mean “______________________”.
   
   d. Electronic Protected Health Information. “Electronic Protected Health Information" or "EPHI" shall have the same meaning as the term “Electronic Protected Health Information" in 45 C.F.R. 160.103, and shall refer to PHI that Covered Entity, or Business Associate on behalf of Covered Entity, transmits or maintains in electronic media.
   
   e. HIPAA Rules. "HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 CFR Part 160 and Part 164.
   
   f. Individual. “Individual” shall have the same meaning as the term "individual" in 45 C.F.R. 160.103 and shall include a person who qualifies as a personal representative in accordance with 45 C.F.R. 164.502(g).
   
   g. Protected Health Information. “Protected Health Information“ or “PHI” as used in this Agreement means (subject to the definition at 45 C.F.R. 160.103) Individually Identifiable Health Information that Business Associate creates, receives, maintains or transmits on behalf of Covered Entity. This Agreement is intended to comply with the requirements for Business Associate agreements under the HIPAA Rules and is to be construed to achieve compliance with those requirements.
   
   h. Underlying Services. “Underlying Services” shall mean the services Covered Entity has engaged Business Associate to provide on Covered Entity’s behalf.
   
   i. Unsecured Protected Health Information. “Unsecured Protected Health Information" or “Unsecured PHI" shall mean PHI that is not rendered unusable, unreadable, or indecipherable to unauthorized individuals through the use of a technology or methodology specified by the Secretary in guidance, as set forth as 45 C.F.R. 164.402.


2. PERMITTED USES AND DISCLOSURES BY BUSINESS ASSOCIATE
   
   a. Stated Purposes. Business Associate is permitted to use and/or disclose PHI as necessary to perform the Underlying Services between the parties (the “Stated Purposes”) and is otherwise prohibited from using or disclosing PHI provided or made available by Covered Entity for any purpose other than as expressly permitted or required by this Agreement.
   
   b. Other Permitted Uses And Disclosures. In addition to the Stated Purposes for which Business Associate may use or disclose PHI, Business Associate may use or disclose PHI provided or made available from Covered Entity for the proper management and administration of Business Associate or to carry out legal responsibilities of Business Associate. Notwithstanding the foregoing, such a use and disclosure is permitted provided that:
   
   The disclosure is Required by Law; or Business Associate obtains reasonable assurances from the person to whom the PHI is disclosed that it will be held confidentially and used or further disclosed only as Required by Law or for the purposes for which it was disclosed to the person; the person will use appropriate safeguards to prevent use or disclosure of the PHI; and the person immediately notifies the Business Associate of any instance of which it is aware in which the confidentiality of the information has been breached.
   
   c. Necessary. Business Associate agrees to make uses and disclosures and requests of PHI consistent with Covered Entity's minimum necessary policies and procedures, such policies and procedures to be provided to Business Associate by Covered Entity concurrent with the execution of the Agreement.
   
   d. Data Aggregation. Business Associate may use or disclose PHI to provide data aggregation services, as that term is defined by 45 C.F.R. 164.501, relating to the health care operations of Covered Entity.
3. OBLIGATIONS AND ACTIVITIES OF BUSINESS ASSOCIATE
   a. Limits On Use And Further Disclosure Established By Agreement or By Law. Business Associate hereby agrees that the PHI provided or made available by Covered Entity shall not be further used or disclosed other than as permitted or required by the Agreement or as Required By Law. Business Associate shall comply with the provisions of this Agreement related to the privacy and security of PHI and all present and future provisions of the HIPAA Rules that are applicable to Covered Entity and/or Business Associate. To the extent Business Associate is to carry out any of Covered Entity’s obligation under the Privacy Rule, Business Associate shall comply with the requirements of the Privacy Rule that apply to Covered Entity in the performance of such obligation.
   
   b. Appropriate Safeguards. Business Associate will establish and maintain appropriate safeguards to prevent any use or disclosure of the PHI, other than as provided for by this Agreement and comply with the Security Rule with respect to electronic PHI.
   
   c. Reports Of Improper Use Or Disclosure. Business Associate hereby agrees that it shall report to Covered Entity within thirty (30) days of discovery any use or disclosure of PHI not provided for or allowed by this Agreement. This provision shall apply to Breaches of Unsecured PHI, as those terms are defined at 45 C.F.R. 164.402. Business Associates notice shall include the applicable elements as set forth at 45 C.F.R. §164.410(c) when Breaches of Unsecured PHI occur.
   
   d. Subcontractors. In accordance with 45 C.F.R. 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, Business Associate hereby agrees to enter into written agreements with any subcontractors that create, receive, maintain, or transmit PHI on behalf of Business Associate, and the terms of such agreements shall incorporate the applicable restrictions, conditions, and requirements that apply to Business Associate with respect to such information as set forth herein.
   
   e. Right of Access to Information. Business Associate hereby agrees to make available and provide a right of access to PHI by an Individual. This right of access shall conform with and meet the requirements set forth at 45 C.F.R. 164.524. The obligations of Business Associate in this paragraph apply only to PHI in Designated Record Sets in Business Associate's possession or control as such term is defined at 45 C.F.R. 164.501.
   
   f. Amendment and Incorporation of Amendments. Business Associate agrees to make PHI available for amendment and to incorporate any amendments to PHI in accordance with 45 C.F.R. 164.526, which describes the requirements applicable to an Individual's request for an amendment to the PHI relating to the Individual. The obligations of Business Associate in this paragraph apply only to PHI in Designated Record Sets in Business Associate’s possession or control as such term is defined at 45 C.F.R. 164.501.
   
   g. Provide Accounting. Business Associate agrees to make PHI and information related to the disclosures available as required to provide an accounting of disclosures in accordance with 45 CPR. 164.528, which describes the requirements applicable to an individual’s request for an accounting of disclosures of PHI relating to the Individual. Business Associate agrees to document such disclosures of PHI and information related to such disclosures as would be required for Covered Entity to respond to a request by an individual for an accounting. In addition, as required by the HITECH Act, effective on such date as the Secretary may specify, if Business Associate uses electronic health records, as defined at 42 U.S.C. 17931, Business Associate will record disclosures through electronic health records for treatment, payment and health care operations purposes, if any, in accordance with the specifications established by the Secretary.
   
   h. Access to Books and Records. Business Associate hereby agrees to make its internal practices, books, and records relating to the use or disclosure of PHI received from, or created or received by Business Associate on behalf of the Covered Entity, available to the Secretary of the Department of Health and Human Services ("HHS"), or the Secretary’s designee, for purposes of determining Covered Entity's compliance with its obligations under HIPAA.
   
   i. Mitigation Procedures. Business Associate agrees to have procedures in place for mitigating, to the maximum extent practicable, any deleterious effect from the use or disclosure of PHI in a manner contrary to this Agreement or the Privacy Rule.
   
   j. Prohibition on Remuneration for PHI. Unless as exception applies, as set forth at 42 U.S.C. 17935(d)(2), in no event may Business Associate directly or indirectly receive remuneration in exchange for any PHI of an Individual unless Covered Entity obtains from the Individual a valid authorization that includes a specification of whether the PHI can be further exchanged for remuneration by the entity receiving PHI of that Individual. This prohibition does not apply to remuneration Business Associate receives from the Covered Entity for activities that the Business Associate undertakes on behalf of and at the specific request of the Covered Entity pursuant to this Agreement.


4. OBLIGATIONS OF COVERED ENTITY
   a. Restrictions in Notice of Privacy Practices. Covered Entity shall notify Business Associate of any limitation(s) in the notice of privacy practices of Covered Entity under 45 C.F.R. 164.520, to the extent that such limitation may affect Business Associate's use or disclosure of PHI.
   
   b. Changes in Permission by Individuals. Covered Entity shall notify Business Associate of any changes in, or revocation of, the permission by an Individual to use or disclose his or her PHI, to the extent that such changes may affect Business Associate's use or disclosure of PH.
   
   c. Agreed-Upon Restrictions. Covered Entity shall notify Business Associate of any restrictions on the use or disclosure of PHI that Covered Entity has agreed to or is required to abide by under 45 C.F.R. 164.522, to the extent that such restriction may affect Business Associate’s use or disclosure of PHI.
   
   d. Permissible Requests. Covered Entity shall not request Business Associate to use or disclose PHI in any manner that would not be permissible under the Privacy Rule if done by the Covered Entity, except that Business Associate may use or disclose PHI for the management and administration and legal responsibilities of the Business Associate as specified herein.


5. ACKNOWLEDGMENT OF OBLIGATIONS
   Business Associate acknowledges that it is directly subject to HIPAA, as amended by the HITECH Act, including, but not limited to, Sections 164.303, 164.310, 164.312 and Section 164.316, as well as the enforcement and penalty provisions HIPAA provides, as they may be amended from time to time. See 42 U.S.C. 17931, 17934. Business Associate agrees that it will (a) comply with all applicable provisions of HIPAA, as amended by the HITECH Act and as it may be further amended from time to time; and (b) not act in any way to interfere with or hinder Covered Entity’s ability to comply with HIPAA, as amended by the HITECH Act and as it may be further amended from time to time.


6. BREACH REPORTING
   a. In the event that either Party has knowledge of a material breach of this Agreement by the other Party, the non-breaching Party may immediately terminate this Agreement.
   
   b. Alternatively, in the event that either Party has knowledge of a material breach of this Agreement by the other Party and cure is possible, the non-breaching Party may provide a reasonable opportunity for the breaching Party to cure the breach or end the violation. If the breaching Party does not cure the breach or end the violation within the time specified by nonbreaching Party, the non-breaching Party may terminate this Agreement.
   
   c. In the event that either Party has knowledge of a material breach of this Agreement by the other Party and cure is not possible, the non-breaching Party shall terminate the portion of the service being perform that is affected by the breach.


7. TERMINATION
   a. This Agreement may be terminated by either Party at any time with the mutual consent of both parties.
   
   b. Upon termination of this Agreement for any reason, if feasible, Business Associate will return or destroy all PHI received from Covered Entity or created or received by Business Associate on behalf of Covered Entity that Business Associate still maintains in any form and retain no copies of such information. If such return or destruction is not feasible, Business Associate will extend the protections of this Agreement to the information retained and limit further uses and disclosures to those purposes that make the return or destruction of the information infeasible. This paragraph shall survive the termination of this Agreement.


8. MISCELLANEOUS
   a. Amendment. This Agreement cannot be amended except by mutual written agreement of Covered Entity and Business Associate.
   
   b. Amendment for Compliance. In the event that any provision of this Agreement is held by a court of competent jurisdiction to be invalid or unenforceable, the remainder of the provisions of the Agreement will remain in full force and effect. In addition, in the event Covered Entity believes in good faith that any provision of the Agreement fails to comply with the then current requirements of the applicable HIPAA regulations, Covered Entity shall notify Business Associate in writing. For a period of up to thirty (30) days, the Parties shall address in good faith such concern and shall amend the terms of this Agreement, if necessary, to bring it into compliance. If after such thirty-day period this Agreement fails to comply with the HIPAA regulations with respect to the concern(s) raised pursuant to this paragraph, Covered Entity has the right to terminate this Agreement upon thirty (30) days' written notice to Business Associate.
   
   c. Binding Nature and Assignment. This Agreement shall be binding on the Parties hereto and their successors and assigns, but neither Party may assign this Agreement without the prior written consent of the other, which consent shall not be unreasonably withheld.
   
   d. Notices. Whenever under this Agreement one Party is required to give notice to the other, such notice shall be deemed given if mailed by First Class United States mail, postage prepaid, and addressed to the address of the Parties included in the signature page of this Agreement.
   Either Party may at anytime change its address for notification purposes by mailing a notice stating the change and setting forth the new address.
   
   e. Force Majeure. Business Associate shall be excused from performance under this Agreement for any period Business Associate is prevented from performing any services pursuant hereto, in whole or in part, as a result of an Act of God, pandemics, war, civil disturbance, hurricanes, court order, pandemic, labor dispute or other cause beyond its reasonable control, and such nonperformance shall not be grounds for termination, except that Business Associate’s inability to perform will not be excused in the event that Business Associate failed to implement a reasonable disaster recovery plan prior to experiencing the event and invoking this provision.
   
   f. No Third Party Beneficiaries. The Parties have not created and do not intend to create by this Agreement any third party rights under this Agreement.
   
   g. Severability. If any provision of this Agreement or any other agreement, document, or writing pursuant to or in connection with this Agreement, is found to be wholly or partially invalid or unenforceable; the remainder of this Agreement is unaffected.
   
   h. Waiver. No term or provision of this Agreement shall be deemed waived and no breach excused unless such waiver or excuse of breach is in writing, signed by the Party against who such waiver or excuse is claimed.
   
   i. Entire Agreement. This Business Associate Agreement consists of this document, and constitutes the entire agreement between the Parties with respect to the subject matter hereof. There are no understandings or agreements relating to this Agreement which are not fully expressed herein and no change, waiver or discharge of obligations arising under this Agreement shall be valid unless in writing and executed by the Party against whom such change, waiver or discharge is sought to be enforced.
   
   j. This Agreement supersedes any and all previous signed Business Associate Agreements between both parties. The terms and conditions of this Business Associate Agreement will replace all previously agreed to PHI storage, handling, reporting, destruction and notification requirements.
   
   k. Governing Law. Except to the extent preempted by federal law, this Agreement shall be governed by and construed in accordance with the laws of the State of Florida.
   
   We have carefully reviewed this contract and agree to and accept its terms and conditions. We are executing this contract as of the day and year first written above.

BUSINESS AGREEMENT AUTHORIZED OFFICER