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THIS BARIATRIC ADVANTAGE ONLINE™ WEBPAGE AGREEMENT – RESALE ESTORE (“Agreement”) is effective as of the date signed by Practitioner (the “Effective Date”) by and between Bariatric Advantage, an operating division of Metagenics LLC, a Delaware limited liability company with offices at 25 Enterprise, Suite 200, Aliso Viejo, CA 92656 (“Bariatric Advantage”), and Practitioner (“Practitioner”).
RECITALS
A. Bariatric Advantage is an operating division of Metagenics LLC, a life sciences company that manufactures nutritional products, dietary supplements, dietary ingredients, and medical foods for sale in commerce based upon Bariatric Advantage’s own formulas or recipes or upon formulas or recipes obtained pursuant to license (or which exist in the public domain).
B. Bariatric Advantage has developed software (the “Software”) for the establishment and operation of separate webpages for the sale of Bariatric Advantage products by healthcare practitioners, which webpages are identified specifically to an individual healthcare practitioner and serve the needs of such individual practitioner’s own patients.
C. Practitioner is interested in establishing a unique webpage (the “Webpage”) on Bariatric Advantage’s website, through which Practitioner will sell Bariatric Advantage products to Practitioner’s patients Bariatric Advantage dietary supplements and medical foods, for the purposes of (i) providing patient convenience, (ii) meeting specified nutritional protocols established by Practitioner, (iii) improving patient compliance with such recommended protocols, and (iv) tracking patients’ actual compliance with such protocols.
D. Bariatric Advantage desires to use Practitioner’s name and logo on the Webpage, and Practitioner is willing to grant Bariatric Advantage the right to use Practitioner’s name and logo on the Webpage, pursuant to the terms and conditions of this Agreement.
NOW, THEREFORE, the parties hereto hereby agree as follows:
1. DEFINITIONS.The terms set forth below shall be defined as follows:
1.1. “Confidential Information” of a party is information which the party claiming confidentiality designates as “Confidential,” including, without limitation, any computer code, Content (as described below), other content, documentation, marketing plans or other similar information. “Confidential Information” of Bariatric Advantage includes the source code of the Software.
1.2. “Software” shall mean all software and any software tools, both in object code and source code form, which Bariatric Advantage has already developed (or which Bariatric Advantage subsequently develops) or which Bariatric Advantage licenses from a third party, for establishing and maintaining Practitioner’s Webpage.
1.3. “Webpage” shall mean the unique page established using Practitioner’s name and logo, on Bariatric Advantage’s own website, using the Software, and maintained and supported on the Bariatric Advantage server.
2. PURPOSE; LICENSE; CONTENT; SERVER; DEVELOPMENT SERVICES.
2.1. Purpose. The purpose of Practitioner’s Webpage shall include, without limitation, the dissemination of information, the display of Bariatric Advantage products for order and purchase, the presentation of advertising, and other purposes.
2.2. License. Practitioner hereby grants to Bariatric Advantage a non-exclusive, non-assignable license to use Practitioner’s name and logo for all uses necessary or appropriate to the operation of Practitioner’s Webpage, in accordance with the terms and conditions of this Agreement.
2.3. Content of the Webpage. The Webpage will be based upon Bariatric Advantage content. The Webpage will use the Software to implement product purchasing, data collection, and information tracking.
2.4. Server for the Webpage. The Software and the Webpage will reside upon a server provided by Bariatric Advantage.
2.5. Development Services. Bariatric Advantage will provide design, programming, development and other services relating to the Webpage.
3. WEBPAGE SUPPORT SERVICES.
Bariatric Advantage shall provide the following ongoing Webpage support to Practitioner.
3.1. Establishment of Webpage on Bariatric Advantage Server. Bariatric Advantage will establish Practitioner’s Webpage as part of Bariatric Advantage’s own website, which is on a server provided by Bariatric Advantage and under Bariatric Advantage’s control, support, and maintenance.
3.2. Availability. Unless otherwise agreed between the parties, Bariatric Advantage shall use commercially reasonable efforts to make Practitioner’s Webpage publicly available to users twenty-four (24) hours per day, seven (7) days per week.
3.3. Content. Practitioner shall not supplement, modify or alter any content on Practitioner’s Webpage, unless any such change has been consented to by Bariatric Advantage. Bariatric Advantage will provide password protected access for Practitioner.
3.4. Backup. Bariatric Advantage shall maintain a complete and current copy of Bariatric Advantage’s website on a separate server. In the event that service is interrupted to Bariatric Advantage’s website, the separate server shall be activated so that public access to Practitioner’s Webpage may continue uninterrupted or as close as possible under the circumstances.
3.5. Privacy Policy; Patient Data. The parties agree that a privacy policy shall exist that conforms with existing privacy laws and shall maintain that policy with respect to Practitioner’s Webpage. Such privacy policy shall be subject to any additional privacy limitations placed by MasterCard, Visa or other Internet payment processing companies through which sales on Practitioner’s Webpage may be charged. Patient data will be maintained on a secure server provided by Bariatric Advantage. Bariatric Advantage will use commercially reasonable efforts to provide Practitioner access to the patient data twenty four (24) hours per day, seven (7) days per week, and Bariatric Advantage will provide Practitioner with passcodes and technical assistance as may be necessary for permitting such access. As a condition precedent to entering this Agreement, the parties agree to execute the HIPAA Business Associate Agreement in the form set forth as Exhibit A hereto.
4. INVENTORY SERVICES.
4.1. Shopping Cart Features. Bariatric Advantage will use its online shopping cart application which will be customized for Practitioner’s webpage to manage the shopping experience of visitors to Practitioner’s Webpage.
4.2. Product Selection for the Webpage. Practitioner is responsible for determining the applicable nutritional protocol, and for selecting the products, to support the needs of the patients who will be directed to Practitioner’s Webpage to purchase products. Bariatric Advantage maintains an on-line catalog of products from which Practitioner may select.
4.3. Ordering from the Webpage. Completed orders will be communicated from Practitioner’s Webpage directly to Bariatric Advantage’s distribution center. Products will be shipped from the distribution center to the patient using shipping documents and shipping labels that include Practitioner’s name and Bariatric Advantage’s return address.
4.4. Inventory Levels. Throughout the Term of this Agreement, Bariatric Advantage shall use commercially reasonable efforts to maintain appropriate levels of inventory at the Bariatric Advantage distribution center to meet patients’ demand for the products listed on Practitioner’s Webpage. Bariatric Advantage will assist in establishing inventory levels to reflect the actual sales performance of each product SKU.
4.5.1. Shipping charges (from the Bariatric Advantage distribution center) will be paid by the patient. Bariatric Advantage will determine and charge the appropriate shipping/handling charge per outgoing order.
4.5.2. Bariatric Advantage will be responsible for undeliverable or damaged shipments from Bariatric Advantage to patients, and Bariatric Advantage will handle such damaged shipments according to its then-current policy regarding such shipments.
4.5.3. Practitioner will specify the satisfaction guarantee policy to which product returns will be subject or, in the absence of such specification, the then-current Bariatric Advantage satisfaction guarantee policy.
4.5.4. Bariatric Advantage will be responsible for product recalls.
4.6. Product Pricing. Bariatric Advantage will recommend to Practitioner a suggested retail price (SRP) for each product SKU offered on Practitioner’s Webpage, but it shall be Practitioner’s responsibility to set the actual retail price to patients.
5. PRICING; REPORTING; PAYMENT; CREDIT AND COLLECTIONS.
5.1. Products. The price from Bariatric Advantage to Practitioner for products purchased by patients from Practitioner’s Webpage shall be Bariatric Advantage’s then-current practitioner price for such products.
5.2. Reporting. Practitioner will have access to sales reports. Within twenty (20) calendar days after the close of each calendar quarter, Bariatric Advantage will provide Practitioner with an accounting of sales made from Practitioner’s Webpage.
5.3. Payment. Practitioner will open Practitioner’s own individual account with the WePay processing service (“WePay”). Patients will purchase products from Practitioner’s Webpage through Practitioner’s WePay account. Patients will make payments for products by an approved method of payment, which shall include providing the Patient’s credit card information to WePay. WePay shall deduct its transaction fees and, on behalf of Practitioner, WePay shall remit to Bariatric Advantage the applicable price for the products purchased by patients on Practitioner’s Webpage.
5.3.1. Bank fees, credit card transaction fees, and WePay transaction fees are included in the price paid by the patient.
5.4. Credit and Collections. Practitioner shall be responsible for credits and collections relating to products purchased through Practitioner’s WePay account.
5.5 Sales Taxes. In all jurisdictions that permit or require a marketplace facilitator, marketplace provider, or other similar person to collect and remit sales, use, transaction privilege, gross receipts, excise or similar transaction taxes (collectively, “Sales Taxes”), Bariatric Advantage will collect and remit Sales Taxes to the appropriate taxing authority. Practitioner agrees to provide Bariatric Advantage with all information to support such treatment, including its Sales Tax registration numbers.
In all other jurisdictions or where Metagenics is not acting as a marketplace facilitator or other similar person, Practitioner shall be responsible to collect and remit Sales Taxes to the appropriate taxing authority. In such non-marketplace facilitator jurisdictions or where Metagenics is not acting as a marketplace facilitator or other similar person, Practitioner agrees that Practitioner will indemnify Bariatric Advantage for all Sales Tax, interest, and penalties asserted or assessed against Bariatric Advantage by a taxing authority with respect to Practitioner’s sales, as well as for reasonable costs to defend against such assertions or assessments.
In all jurisdictions, Practitioner agrees that Practitioner will indemnify and hold harmless Bariatric Advantage from all losses related to assessments. false claims, qui tam, and class action lawsuits with respect to Practitioner’s sales that may arise in such jurisdictions and that relate to the correct taxability of an item or the correct tax rate.
6. PATIENT SUPPORT.
6.1 Practitioner Responsibility. Practitioner shall be responsible for recommending particular products for use by the patient, including how much, how often, and for how long such products should be used. Practitioner will be responsible for tracking protocol compliance on the part of patients. Practitioner agrees that Practitioner shall only use the Webpage and the Software to communicate with patients for purposes that are permitted under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, “HIPAA”) and other applicable law, such as for treatment purposes.
6.2 Bariatric Advantage Responsibility. Bariatric Advantage shall be responsible for providing customer service for patients ordering products from Practitioner’s Webpage, as said service relates to informing patients of product specifications, shipment status, return authorizations, product promotions, and similar matters. At the direction of Practitioner, Bariatric Advantage will use patient information to communicate with patients about refill reminders or about the availability of other products that Practitioner believes may aid in the treatment of the patient.
6.3 Communications. Throughout each business day, on a necessary and appropriate basis (and in real time, if required), each party will keep the other informed of the support provided to patients.
7. TERM AND TERMINATION.
7.1. Term. This Agreement shall have an initial term of one (1) year from the Effective Date (the “Initial Term”); thereafter, this Agreement may be renewed for additional terms of one (1) year (each, a “Renewal Term” and, together with the Initial Term, the “Term”) and shall be considered automatically so renewed if neither party has given the other written notice of intention to terminate this Agreement at least sixty (60) days prior to the expiration of the Initial Term or the then-current Renewal Term.
7.2. Termination for Cause. Either party may terminate this Agreement upon a material breach of this Agreement by the other party (or, in the case of a breach by Practitioner, the breach of an applicable Bariatric Advantage policy), if such breach remains uncured for thirty (30) days following written notice to the breaching party.
7.3. Termination without Cause. Either party may terminate this Agreement, at any time, without cause, by giving at least ninety (90) days’ prior written notice to the other party.
7.4. Effect of Termination.
7.4.1 Removal of Name and logo. Upon the termination of this Agreement for any reason, Bariatric Advantage shall promptly remove Practitioner’s name and logo from the Webpage and shall use commercially reasonable efforts to remove any references to Practitioner’s name and logo from Bariatric Advantage’s website.
7.4.2 Termination of Licenses. Upon termination of this Agreement for any reason, any license granted hereunder shall terminate.
7.4.3 Survival. Sections10, 11, 12, and 13 shall survive any termination or expiration of this Agreement.
8. BARIATRIC ADVANTAGE WARRANTIES.
8.1. Work Product Warranties. Bariatric Advantage represents and warrants to Practitioner that the Software, the Webpage, and Bariatric Advantage-made changes to the Webpage do not and will not (a) infringe on the intellectual property rights of any third party or (b) violate any law or regulation.
8.2. Support and Maintenance Warranties. Bariatric Advantage further represents and warrants to Practitioner that, at all times during which Bariatric Advantage provides web-hosting services pursuant to Section 3 of this Agreement, it will use commercially reasonable efforts to ensure the following:
8.2.1. Availability of the Webpage. The Webpage will be publicly available to users a minimum of ninety-five percent (95%) of the time, seven (7) days per week, twenty-four (24) hours per day. Customer Service will be available during business hours, Monday through Friday, 8:00 am – 5:00 pm (Pacific Time).
8.2.2. Bandwidth of Bariatric Advantage’s Website. The Bariatric Advantage website’s connection to the Internet shall be sufficient to provide accessibility commensurate with that expected by the consuming public and of a grade equal to that provided by similar sites. The goal shall be to prevent any user delays from accessing Practitioner’s Webpage, subject to Internet-related delays that are not within Bariatric Advantage’s control.
8.2.3. Security of Bariatric Advantage’s Website. Bariatric Advantage shall prevent unauthorized access to any shadow site of its website, other restricted areas of its website, and any databases or other sensitive material generated from or used in conjunction with its website, provided, however, that Practitioner understands and acknowledges that Bariatric Advantage shall not be held responsible for the effects of malicious hacking or other concerted criminal and illegal activities on the part of third parties in relation hereto.
9. PRACTITIONER WARRANTIES.
Practitioner represents and warrants that Practitioner will not use any advertising material with respect to the products available on Practitioner’s Webpage that: (a) infringes any intellectual property right of any third party, (b) is false or provides a misleading statement of material fact or (c) violates any law or regulation.
10. OWNERSHIP.
10.1. Ownership of the Website. Practitioner acknowledges and agrees that Bariatric Advantage owns the Software and all of the computer code on, and relating to, Bariatric Advantage’s website.
10.2. Ownership of Content. All content contributed by Bariatric Advantage shall be owned by Bariatric Advantage. Practitioner acknowledges and agrees that any content used on Practitioner’s Webpage shall at all times remain the property of Bariatric Advantage (or its licensor). Practitioner shall have no rights in such content, other than the limited right to use such content for the purposes expressly set forth in this Agreement.
11. INDEMNIFICATION.
11.1. Bariatric Advantage Indemnification. Bariatric Advantage shall defend and hold harmless Practitioner against any third party claim, action, suit or proceeding (each, a “Claim”) (a) arising from any breach of this Agreement by Bariatric Advantage, (b) arising from the negligent acts or omissions or the willful misconduct of Bariatric Advantage or (c) alleging product liability or other Claim relating to the integrity of a Bariatric Advantage product. Bariatric Advantage shall indemnify Practitioner for losses, damages, liabilities and reasonable expenses (including, without limitation, reasonable attorneys’ fees) and costs incurred by Practitioner in defending against any such Claim.
11.2. Practitioner Indemnification. Practitioner shall defend and hold harmless Bariatric Advantage against any Claim (a) arising from any breach of this Agreement by Practitioner or (b) arising from the negligent acts or omissions or the willful misconduct of Practitioner. Practitioner shall indemnify Bariatric Advantage for losses, damages, liabilities and reasonable expenses (including, without limitation, reasonable attorneys’ fees) and costs incurred by Bariatric Advantage in defending against any such Claim.
11.3. Mechanics of Indemnification. The indemnified party’s obligations are conditioned upon the indemnified party: (a) giving the indemnifying party prompt written notice of any Claim for which the indemnified party is seeking indemnity; (b) granting control of the defense and settlement of such Claim to the indemnifying party; and (c) reasonably cooperating with the indemnifying party at the indemnifying party’s expense.
12. CONFIDENTIAL INFORMATION.
Each party shall hold the Confidential Information of the other party in confidence and shall not (i) disclose the other party’s Confidential Information to third parties or (ii) use the other party’s Confidential Information for any purpose other than the purposes of this Agreement. Such restrictions shall not apply to information which (a) is already known by the recipient; (b) becomes, through no act or fault of the recipient, publicly known; (c) is received by the recipient from a third party without a restriction on disclosure or use; or (d) is independently developed by the recipient without reference to the other party’s Confidential Information.
13. LIMITATION ON LIABILITY.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR TO ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY OR PUNITIVE DAMAGES, HOWEVER CAUSED, WHETHER FOR BREACH OF CONTRACT, TORT, NEGLIGENCE, STRICT PRODUCT LIABILITY OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, DAMAGES BASED ON LOSS OF PROFITS OR BUSINESS OPPORTUNITY), EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
14. EXCLUSIVITY; NON-COMPETITION.
Practitioner acknowledges that Bariatric Advantage is in the business of developing its own website and of providing associated services on a commercial basis and that, accordingly, Bariatric Advantage has developed, and will continue to develop, webpages for other parties whom Practitioner may consider competitive to Practitioner’s business. Practitioner agrees that Bariatric Advantage shall continue to be free to develop webpages for other clients. Bariatric Advantage shall not share with its other clients any identifiable data pertaining to Practitioner’s Webpage.
15. COMPLIANCE WITH LAWS.
Each party shall perform its respective obligations under this Agreement in compliance with the applicable laws of the jurisdictions in which this Agreement is intended to be performed.
16. GENERAL PROVISIONS.
16.1. Governing Law; Venue. This Agreement shall be governed by, and construed in accordance with, the laws of the State of California, without regard to conflict of law principles. In the event that any dispute arises under this Agreement, the parties agree that proceedings will take place exclusively in the County of Orange, State of California.
16.2. Severability; No Waiver. If any provision of this Agreement is held to be invalid or unenforceable for any reason, the remaining provisions will continue in full force without being impaired or invalidated in any way. The parties agree to replace any invalid provision with a valid provision that most closely approximates the intent and economic effect of the invalid provision. A waiver by either party of a breach of any provision of this Agreement will not operate or be interpreted as a waiver of any other or subsequent breach.
16.3. Independent Contractors. The parties to this Agreement are independent contractors and no agency, partnership, joint venture or employee-employer relationship is intended or created by this Agreement. Except as contemplated by the obligations of each party under this Agreement, neither party shall have the power to obligate or bind the other party. Personnel supplied by Bariatric Advantage shall work exclusively for Bariatric Advantage and shall not, for any purpose, be considered employees or agents of Practitioner.
16.4. Entire Agreement; Amendment. This Agreement, including any exhibits attached hereto and the provisions referenced in such Exhibits, sets forth the entire understanding and agreement of the parties and supersedes any and all oral or written agreements or understandings between the parties as to the subject matter of this Agreement. Any amendments or changes to this Agreement must be in writing and signed by both parties.
EXHIBIT A
HIPAA Business Associate Agreement
THIS HIPAA BUSINESS ASSOCIATE AGREEMENT (this “Business Associate Agreement”) between Practitioner (“Practitioner” or “Covered Entity”) and Bariatric Advantage, an operating division of Metagenics LLC, a Delaware limited liability company with offices at 25 Enterprise, Suite 200, Aliso Viejo, CA 92656 (“Bariatric Advantage” or “Business Associate”) is effective as of the same date as the effective date of that certain BARIATRIC ADVANTAGE ONLINE™ WEBPAGE AGREEMENT – RECOMMENDATION ESTORE between Practitioner and Bariatric Advantage (the “Effective Date”).
WHEREAS, Practitioner is disclosing and/or making available certain data, which may include Protected Health Information as that term is defined in 45 C.F.R. § 160.103, to Bariatric Advantage;
WHEREAS, Practitioner has requested that Bariatric Advantage enter into a business associate agreement;
WHEREAS, Bariatric Advantage is willing, given its commitment to privacy and security protections, to sign a business associate agreement with Practitioner;
WHEREAS, Practitioner is or may be subject to the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and privacy and security regulations promulgated thereunder (45 C.F.R. Parts 160 and 164) (the “Privacy Regulations” and the “Security Regulations”);
WHEREAS, Practitioner and Bariatric Advantage seek to comply with those provisions under Subtitle D (Privacy) of the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) that apply to covered entities and business associates, respectively; and
WHEREAS, Bariatric Advantage shall use Practitioner’s Protected Health Information as mutually agreed by the Parties (“the Activities”);
NOW, THEREFORE, the parties agree as follows:
Definitions.
A. Catch-all 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.
B. Specific definitions.
“Business Associate” shall generally have the same meaning as the term “business associate” at 45 C.F.R. § 160.103 and, in reference to the party to this Agreement, shall mean Bariatric Advantage, an operating division of Metagenics LLC.
“Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 C.F.R. § 160.103 and, in reference to the party to this Agreement, shall mean Practitioner.
“HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 C.F.R. Part 160 and Part 164.
II. Obligations and Activities of Business Associate.
Business Associate agrees to:
Not use or disclose Protected Health Information other than as permitted or required by this Agreement or as Required By Law;
Use appropriate safeguards, and comply with Subpart C of 45 C.F.R. Part 164 with respect to electronic Protected Health Information, to prevent use or disclosure of Protected Health Information other than as provided for by this Agreement;
Report to Covered Entity any use or disclosure of Protected Health Information not provided for by this Agreement of which it becomes aware, including Breaches of Unsecured Protected Health Information as required at 45 C.F.R. § 164.410, and any Security Incident of which it becomes aware;
In accordance with 45 C.F.R. §§ 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any Subcontractors that create, receive, maintain, or transmit Protected Health Information on behalf of Business Associate agree to the same restrictions, conditions, and requirements that apply to Business Associate with respect to such information;
Make available Protected Health Information in a Designated Record Set to Covered Entity as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.524;
Make any amendment(s) to Protected Health Information in a Designated Record Set as directed or agreed to by Covered Entity pursuant to 45 C.F.R. § 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 C.F.R § 164.526;
Maintain and make available the information required to provide an accounting of disclosures to Covered Entity as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.528;
To the extent Business Associate is to carry out one or more of Covered Entity’s obligation(s) under Subpart E of 45 C.F.R. Part 164, comply with the requirements of Subpart E that apply to Covered Entity in the performance of such obligation(s); and
Make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.
III. Permitted Uses and Disclosures by Business Associate.
A. Business Associate may only use or disclose Protected Health Information as required to satisfy its obligations to perform the Activities or as otherwise permitted herein.
B. Business Associate is authorized to use Protected Health Information to de-identify the information in accordance with 45 C.F.R. § 164.514(a)-(c).
C. Business associate may use or disclose Protected Health Information as Required By Law (as that term is defined in 45 C.F.R. § 164.103).
D. Business Associate agrees to make uses and disclosures and requests for Protected Health Information, consistent with the Minimum Necessary requirement, as applicable.
E. Business Associate may not use or disclose Protected Health Information in a manner that would violate Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, except for the specific uses and disclosures set forth below in paragraphs F, G, H, and I of this Section III (“Permitted Uses and Disclosures”).
F. Business Associate may use Protected Health Information to contact patients and offer such patients an authorization for the use and disclosure of Protected Health Information that complies with 45 C.F.R. § 164.508. If a patient chooses to sign such an authorization, Business Associate may use and disclose Protected Health Information to the extent permitted by the authorization, including to market Business Associate’s products.
G. Business Associate may use Protected Health Information for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate.
H. Business Associate may disclose Protected Health Information for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate, provided the disclosures are Required By Law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as Required By Law or for the purposes for which it was disclosed to the person, and the person notifies Business Associate of any instances of which it is aware in which the confidentiality of the information has been Breached.
I. Business Associate may perform Data Aggregation activities relating to the Health Care Operations of Covered Entity.
IV.Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions.
A. 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 Protected Health Information.
B. 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 Protected Health Information, to the extent that such changes may affect Business Associate’s use or disclosure of Protected Health Information.
C. Covered Entity shall notify Business Associate of any restriction on the use or disclosure of Protected Health Information 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 Protected Health Information.
V. Permissible Requests by Covered Entity. Covered Entity shall not request Business Associate to use or disclose Protected Health Information in any manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, provided, however, that this restriction shall not apply for uses or disclosures of Protected Health Information for Data Aggregation activities performed by Business Associate or for the management and administration and legal responsibilities of Business Associate.
VI. Term and Termination.
A. Term. The Term of this Agreement shall be effective as of the Effective Date, and shall terminate when Business Associate has completed performance of the Activities or when either party terminates for cause as authorized in paragraph B of this Section VI (“Term and Termination”), whichever is sooner.
B. Termination for Cause. Business Associate authorizes termination of this Agreement by Covered Entity, if Covered Entity determines Business Associate has violated a material term of this Agreement and Business Associate has not cured the violation or ended the violation within the time reasonably specified by Covered Entity. Covered Entity likewise authorizes termination of this Agreement by Business Associate, if Business Associate determines Covered Entity has violated a material term of this Agreement and Covered Entity has not cured the violation or ended the violation within the time reasonably specified by Business Associate.
C. Obligations of Business Associate upon Termination. Upon termination of this Agreement for any reason, Business Associate, with respect to Protected Health Information received from Covered Entity, or created, maintained, or received by Business Associate on behalf of Covered Entity, shall:
Retain only that Protected Health Information which is necessary for Business Associate to continue its proper management and administration or to carry out its legal responsibilities;
Return to Covered Entity or, if agreed to by Covered Entity, destroy the remaining Protected Health Information that Business Associate still maintains in any form;
Continue to use appropriate safeguards and comply with Subpart C of 45 C.F.R. Part 164 with respect to electronic Protected Health Information to prevent use or disclosure of the Protected Health Information, other than as provided for in this Section, for as long as Business Associate retains the Protected Health Information;
Not use or disclose the Protected Health Information retained by Business Associate other than for the purposes for which such Protected Health Information was retained and subject to the same conditions set out at paragraphs F, G, H, and I of Section III (“Permitted Uses and Disclosures”), which applied prior to termination; and
Return to Covered Entity or, if agreed to by Covered Entity, destroy the Protected Health Information retained by Business Associate when it is no longer needed by Business Associate for its proper management and administration or to carry out its legal responsibilities.
D. Survival. The obligations of Business Associate under this Section shall survive the termination of this Agreement.
VII. Miscellaneous.
A. Regulatory References. A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.
B. Amendment. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for compliance with the requirements of the HIPAA Rules and any other applicable law.
C. Interpretation. Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.
D. Notices. All notices required or permitted by this Agreement shall be in writing and shall be directed to the appropriate party at its address set forth above or such other address as a party may, from time to time, designate by written notice to the other party.
THIS BARIATRIC ADVANTAGE ONLINE™ WEBPAGE AGREEMENT – RESALE ESTORE (“Agreement”) is effective as of the date signed by Practitioner (the “Effective Date”) by and between Bariatric Advantage, an operating division of Metagenics LLC, a Delaware limited liability company with offices at 25 Enterprise, Suite 200, Aliso Viejo, CA 92656 (“Bariatric Advantage”), and Practitioner (“Practitioner”).
RECITALS
A. Bariatric Advantage is an operating division of Metagenics LLC, a life sciences company that manufactures nutritional products, dietary supplements, dietary ingredients, and medical foods for sale in commerce based upon Bariatric Advantage’s own formulas or recipes or upon formulas or recipes obtained pursuant to license (or which exist in the public domain).
B. Bariatric Advantage has developed software (the “Software”) for the establishment and operation of separate webpages for the sale of Bariatric Advantage products by healthcare practitioners, which webpages are identified specifically to an individual healthcare practitioner and serve the needs of such individual practitioner’s own patients.
C. Practitioner is interested in establishing a unique webpage (the “Webpage”) on Bariatric Advantage’s website, through which Practitioner will sell Bariatric Advantage products to Practitioner’s patients Bariatric Advantage dietary supplements and medical foods, for the purposes of (i) providing patient convenience, (ii) meeting specified nutritional protocols established by Practitioner, (iii) improving patient compliance with such recommended protocols, and (iv) tracking patients’ actual compliance with such protocols.
D. Bariatric Advantage desires to use Practitioner’s name and logo on the Webpage, and Practitioner is willing to grant Bariatric Advantage the right to use Practitioner’s name and logo on the Webpage, pursuant to the terms and conditions of this Agreement.
NOW, THEREFORE, the parties hereto hereby agree as follows:
1. DEFINITIONS.The terms set forth below shall be defined as follows:
1.1. “Confidential Information” of a party is information which the party claiming confidentiality designates as “Confidential,” including, without limitation, any computer code, Content (as described below), other content, documentation, marketing plans or other similar information. “Confidential Information” of Bariatric Advantage includes the source code of the Software.
1.2. “Software” shall mean all software and any software tools, both in object code and source code form, which Bariatric Advantage has already developed (or which Bariatric Advantage subsequently develops) or which Bariatric Advantage licenses from a third party, for establishing and maintaining Practitioner’s Webpage.
1.3. “Webpage” shall mean the unique page established using Practitioner’s name and logo, on Bariatric Advantage’s own website, using the Software, and maintained and supported on the Bariatric Advantage server.
2. PURPOSE; LICENSE; CONTENT; SERVER; DEVELOPMENT SERVICES.
2.1. Purpose. The purpose of Practitioner’s Webpage shall include, without limitation, the dissemination of information, the display of Bariatric Advantage products for order and purchase, the presentation of advertising, and other purposes.
2.2. License. Practitioner hereby grants to Bariatric Advantage a non-exclusive, non-assignable license to use Practitioner’s name and logo for all uses necessary or appropriate to the operation of Practitioner’s Webpage, in accordance with the terms and conditions of this Agreement.
2.3. Content of the Webpage. The Webpage will be based upon Bariatric Advantage content. The Webpage will use the Software to implement product purchasing, data collection, and information tracking.
2.4. Server for the Webpage. The Software and the Webpage will reside upon a server provided by Bariatric Advantage.
2.5. Development Services. Bariatric Advantage will provide design, programming, development and other services relating to the Webpage.
3. WEBPAGE SUPPORT SERVICES.
Bariatric Advantage shall provide the following ongoing Webpage support to Practitioner.
3.1. Establishment of Webpage on Bariatric Advantage Server. Bariatric Advantage will establish Practitioner’s Webpage as part of Bariatric Advantage’s own website, which is on a server provided by Bariatric Advantage and under Bariatric Advantage’s control, support, and maintenance.
3.2. Availability. Unless otherwise agreed between the parties, Bariatric Advantage shall use commercially reasonable efforts to make Practitioner’s Webpage publicly available to users twenty-four (24) hours per day, seven (7) days per week.
3.3. Content. Practitioner shall not supplement, modify or alter any content on Practitioner’s Webpage, unless any such change has been consented to by Bariatric Advantage. Bariatric Advantage will provide password protected access for Practitioner.
3.4. Backup. Bariatric Advantage shall maintain a complete and current copy of Bariatric Advantage’s website on a separate server. In the event that service is interrupted to Bariatric Advantage’s website, the separate server shall be activated so that public access to Practitioner’s Webpage may continue uninterrupted or as close as possible under the circumstances.
3.5. Privacy Policy; Patient Data. The parties agree that a privacy policy shall exist that conforms with existing privacy laws and shall maintain that policy with respect to Practitioner’s Webpage. Such privacy policy shall be subject to any additional privacy limitations placed by MasterCard, Visa or other Internet payment processing companies through which sales on Practitioner’s Webpage may be charged. Patient data will be maintained on a secure server provided by Bariatric Advantage. Bariatric Advantage will use commercially reasonable efforts to provide Practitioner access to the patient data twenty four (24) hours per day, seven (7) days per week, and Bariatric Advantage will provide Practitioner with passcodes and technical assistance as may be necessary for permitting such access. As a condition precedent to entering this Agreement, the parties agree to execute the HIPAA Business Associate Agreement in the form set forth as Exhibit A hereto.
4. INVENTORY SERVICES.
4.1. Shopping Cart Features. Bariatric Advantage will use its online shopping cart application which will be customized for Practitioner’s webpage to manage the shopping experience of visitors to Practitioner’s Webpage.
4.2. Product Selection for the Webpage. Practitioner is responsible for determining the applicable nutritional protocol, and for selecting the products, to support the needs of the patients who will be directed to Practitioner’s Webpage to purchase products. Bariatric Advantage maintains an on-line catalog of products from which Practitioner may select.
4.3. Ordering from the Webpage. Completed orders will be communicated from Practitioner’s Webpage directly to Bariatric Advantage’s distribution center. Products will be shipped from the distribution center to the patient using shipping documents and shipping labels that include Practitioner’s name and Bariatric Advantage’s return address.
4.4. Inventory Levels. Throughout the Term of this Agreement, Bariatric Advantage shall use commercially reasonable efforts to maintain appropriate levels of inventory at the Bariatric Advantage distribution center to meet patients’ demand for the products listed on Practitioner’s Webpage. Bariatric Advantage will assist in establishing inventory levels to reflect the actual sales performance of each product SKU.
4.5.1. Shipping charges (from the Bariatric Advantage distribution center) will be paid by the patient. Bariatric Advantage will determine and charge the appropriate shipping/handling charge per outgoing order.
4.5.2. Bariatric Advantage will be responsible for undeliverable or damaged shipments from Bariatric Advantage to patients, and Bariatric Advantage will handle such damaged shipments according to its then-current policy regarding such shipments.
4.5.3. Practitioner will specify the satisfaction guarantee policy to which product returns will be subject or, in the absence of such specification, the then-current Bariatric Advantage satisfaction guarantee policy.
4.5.4. Bariatric Advantage will be responsible for product recalls.
4.6. Product Pricing. Bariatric Advantage will recommend to Practitioner a suggested retail price (SRP) for each product SKU offered on Practitioner’s Webpage, but it shall be Practitioner’s responsibility to set the actual retail price to patients.
5. PRICING; REPORTING; PAYMENT; CREDIT AND COLLECTIONS.
5.1. Products. The price from Bariatric Advantage to Practitioner for products purchased by patients from Practitioner’s Webpage shall be Bariatric Advantage’s then-current practitioner price for such products.
5.2. Reporting. Practitioner will have access to sales reports. Within twenty (20) calendar days after the close of each calendar quarter, Bariatric Advantage will provide Practitioner with an accounting of sales made from Practitioner’s Webpage.
5.3. Payment. Practitioner will open Practitioner’s own individual account with the WePay processing service (“WePay”). Patients will purchase products from Practitioner’s Webpage through Practitioner’s WePay account. Patients will make payments for products by an approved method of payment, which shall include providing the Patient’s credit card information to WePay. WePay shall deduct its transaction fees and, on behalf of Practitioner, WePay shall remit to Bariatric Advantage the applicable price for the products purchased by patients on Practitioner’s Webpage.
5.3.1. Bank fees, credit card transaction fees, and WePay transaction fees are included in the price paid by the patient.
5.4. Credit and Collections. Practitioner shall be responsible for credits and collections relating to products purchased through Practitioner’s WePay account.
5.5 Sales Taxes. In all jurisdictions that permit or require a marketplace facilitator, marketplace provider, or other similar person to collect and remit sales, use, transaction privilege, gross receipts, excise or similar transaction taxes (collectively, “Sales Taxes”), Bariatric Advantage will collect and remit Sales Taxes to the appropriate taxing authority. Practitioner agrees to provide Bariatric Advantage with all information to support such treatment, including its Sales Tax registration numbers.
In all other jurisdictions or where Metagenics is not acting as a marketplace facilitator or other similar person, Practitioner shall be responsible to collect and remit Sales Taxes to the appropriate taxing authority. In such non-marketplace facilitator jurisdictions or where Metagenics is not acting as a marketplace facilitator or other similar person, Practitioner agrees that Practitioner will indemnify Bariatric Advantage for all Sales Tax, interest, and penalties asserted or assessed against Bariatric Advantage by a taxing authority with respect to Practitioner’s sales, as well as for reasonable costs to defend against such assertions or assessments.
In all jurisdictions, Practitioner agrees that Practitioner will indemnify and hold harmless Bariatric Advantage from all losses related to assessments. false claims, qui tam, and class action lawsuits with respect to Practitioner’s sales that may arise in such jurisdictions and that relate to the correct taxability of an item or the correct tax rate.
6. PATIENT SUPPORT.
6.1 Practitioner Responsibility. Practitioner shall be responsible for recommending particular products for use by the patient, including how much, how often, and for how long such products should be used. Practitioner will be responsible for tracking protocol compliance on the part of patients. Practitioner agrees that Practitioner shall only use the Webpage and the Software to communicate with patients for purposes that are permitted under the Health Insurance Portability and Accountability Act of 1996 and its implementing regulations (collectively, “HIPAA”) and other applicable law, such as for treatment purposes.
6.2 Bariatric Advantage Responsibility. Bariatric Advantage shall be responsible for providing customer service for patients ordering products from Practitioner’s Webpage, as said service relates to informing patients of product specifications, shipment status, return authorizations, product promotions, and similar matters. At the direction of Practitioner, Bariatric Advantage will use patient information to communicate with patients about refill reminders or about the availability of other products that Practitioner believes may aid in the treatment of the patient.
6.3 Communications. Throughout each business day, on a necessary and appropriate basis (and in real time, if required), each party will keep the other informed of the support provided to patients.
7. TERM AND TERMINATION.
7.1. Term. This Agreement shall have an initial term of one (1) year from the Effective Date (the “Initial Term”); thereafter, this Agreement may be renewed for additional terms of one (1) year (each, a “Renewal Term” and, together with the Initial Term, the “Term”) and shall be considered automatically so renewed if neither party has given the other written notice of intention to terminate this Agreement at least sixty (60) days prior to the expiration of the Initial Term or the then-current Renewal Term.
7.2. Termination for Cause. Either party may terminate this Agreement upon a material breach of this Agreement by the other party (or, in the case of a breach by Practitioner, the breach of an applicable Bariatric Advantage policy), if such breach remains uncured for thirty (30) days following written notice to the breaching party.
7.3. Termination without Cause. Either party may terminate this Agreement, at any time, without cause, by giving at least ninety (90) days’ prior written notice to the other party.
7.4. Effect of Termination.
7.4.1 Removal of Name and logo. Upon the termination of this Agreement for any reason, Bariatric Advantage shall promptly remove Practitioner’s name and logo from the Webpage and shall use commercially reasonable efforts to remove any references to Practitioner’s name and logo from Bariatric Advantage’s website.
7.4.2 Termination of Licenses. Upon termination of this Agreement for any reason, any license granted hereunder shall terminate.
7.4.3 Survival. Sections10, 11, 12, and 13 shall survive any termination or expiration of this Agreement.
8. BARIATRIC ADVANTAGE WARRANTIES.
8.1. Work Product Warranties. Bariatric Advantage represents and warrants to Practitioner that the Software, the Webpage, and Bariatric Advantage-made changes to the Webpage do not and will not (a) infringe on the intellectual property rights of any third party or (b) violate any law or regulation.
8.2. Support and Maintenance Warranties. Bariatric Advantage further represents and warrants to Practitioner that, at all times during which Bariatric Advantage provides web-hosting services pursuant to Section 3 of this Agreement, it will use commercially reasonable efforts to ensure the following:
8.2.1. Availability of the Webpage. The Webpage will be publicly available to users a minimum of ninety-five percent (95%) of the time, seven (7) days per week, twenty-four (24) hours per day. Customer Service will be available during business hours, Monday through Friday, 8:00 am – 5:00 pm (Pacific Time).
8.2.2. Bandwidth of Bariatric Advantage’s Website. The Bariatric Advantage website’s connection to the Internet shall be sufficient to provide accessibility commensurate with that expected by the consuming public and of a grade equal to that provided by similar sites. The goal shall be to prevent any user delays from accessing Practitioner’s Webpage, subject to Internet-related delays that are not within Bariatric Advantage’s control.
8.2.3. Security of Bariatric Advantage’s Website. Bariatric Advantage shall prevent unauthorized access to any shadow site of its website, other restricted areas of its website, and any databases or other sensitive material generated from or used in conjunction with its website, provided, however, that Practitioner understands and acknowledges that Bariatric Advantage shall not be held responsible for the effects of malicious hacking or other concerted criminal and illegal activities on the part of third parties in relation hereto.
9. PRACTITIONER WARRANTIES.
Practitioner represents and warrants that Practitioner will not use any advertising material with respect to the products available on Practitioner’s Webpage that: (a) infringes any intellectual property right of any third party, (b) is false or provides a misleading statement of material fact or (c) violates any law or regulation.
10. OWNERSHIP.
10.1. Ownership of the Website. Practitioner acknowledges and agrees that Bariatric Advantage owns the Software and all of the computer code on, and relating to, Bariatric Advantage’s website.
10.2. Ownership of Content. All content contributed by Bariatric Advantage shall be owned by Bariatric Advantage. Practitioner acknowledges and agrees that any content used on Practitioner’s Webpage shall at all times remain the property of Bariatric Advantage (or its licensor). Practitioner shall have no rights in such content, other than the limited right to use such content for the purposes expressly set forth in this Agreement.
11. INDEMNIFICATION.
11.1. Bariatric Advantage Indemnification. Bariatric Advantage shall defend and hold harmless Practitioner against any third party claim, action, suit or proceeding (each, a “Claim”) (a) arising from any breach of this Agreement by Bariatric Advantage, (b) arising from the negligent acts or omissions or the willful misconduct of Bariatric Advantage or (c) alleging product liability or other Claim relating to the integrity of a Bariatric Advantage product. Bariatric Advantage shall indemnify Practitioner for losses, damages, liabilities and reasonable expenses (including, without limitation, reasonable attorneys’ fees) and costs incurred by Practitioner in defending against any such Claim.
11.2. Practitioner Indemnification. Practitioner shall defend and hold harmless Bariatric Advantage against any Claim (a) arising from any breach of this Agreement by Practitioner or (b) arising from the negligent acts or omissions or the willful misconduct of Practitioner. Practitioner shall indemnify Bariatric Advantage for losses, damages, liabilities and reasonable expenses (including, without limitation, reasonable attorneys’ fees) and costs incurred by Bariatric Advantage in defending against any such Claim.
11.3. Mechanics of Indemnification. The indemnified party’s obligations are conditioned upon the indemnified party: (a) giving the indemnifying party prompt written notice of any Claim for which the indemnified party is seeking indemnity; (b) granting control of the defense and settlement of such Claim to the indemnifying party; and (c) reasonably cooperating with the indemnifying party at the indemnifying party’s expense.
12. CONFIDENTIAL INFORMATION.
Each party shall hold the Confidential Information of the other party in confidence and shall not (i) disclose the other party’s Confidential Information to third parties or (ii) use the other party’s Confidential Information for any purpose other than the purposes of this Agreement. Such restrictions shall not apply to information which (a) is already known by the recipient; (b) becomes, through no act or fault of the recipient, publicly known; (c) is received by the recipient from a third party without a restriction on disclosure or use; or (d) is independently developed by the recipient without reference to the other party’s Confidential Information.
13. LIMITATION ON LIABILITY.
NEITHER PARTY SHALL BE LIABLE TO THE OTHER PARTY OR TO ANY OTHER PERSON OR ENTITY FOR ANY SPECIAL, CONSEQUENTIAL, INCIDENTAL, INDIRECT, EXEMPLARY OR PUNITIVE DAMAGES, HOWEVER CAUSED, WHETHER FOR BREACH OF CONTRACT, TORT, NEGLIGENCE, STRICT PRODUCT LIABILITY OR OTHERWISE (INCLUDING, WITHOUT LIMITATION, DAMAGES BASED ON LOSS OF PROFITS OR BUSINESS OPPORTUNITY), EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
14. EXCLUSIVITY; NON-COMPETITION.
Practitioner acknowledges that Bariatric Advantage is in the business of developing its own website and of providing associated services on a commercial basis and that, accordingly, Bariatric Advantage has developed, and will continue to develop, webpages for other parties whom Practitioner may consider competitive to Practitioner’s business. Practitioner agrees that Bariatric Advantage shall continue to be free to develop webpages for other clients. Bariatric Advantage shall not share with its other clients any identifiable data pertaining to Practitioner’s Webpage.
15. COMPLIANCE WITH LAWS.
Each party shall perform its respective obligations under this Agreement in compliance with the applicable laws of the jurisdictions in which this Agreement is intended to be performed.
16. GENERAL PROVISIONS.
16.1. Governing Law; Venue. This Agreement shall be governed by, and construed in accordance with, the laws of the State of California, without regard to conflict of law principles. In the event that any dispute arises under this Agreement, the parties agree that proceedings will take place exclusively in the County of Orange, State of California.
16.2. Severability; No Waiver. If any provision of this Agreement is held to be invalid or unenforceable for any reason, the remaining provisions will continue in full force without being impaired or invalidated in any way. The parties agree to replace any invalid provision with a valid provision that most closely approximates the intent and economic effect of the invalid provision. A waiver by either party of a breach of any provision of this Agreement will not operate or be interpreted as a waiver of any other or subsequent breach.
16.3. Independent Contractors. The parties to this Agreement are independent contractors and no agency, partnership, joint venture or employee-employer relationship is intended or created by this Agreement. Except as contemplated by the obligations of each party under this Agreement, neither party shall have the power to obligate or bind the other party. Personnel supplied by Bariatric Advantage shall work exclusively for Bariatric Advantage and shall not, for any purpose, be considered employees or agents of Practitioner.
16.4. Entire Agreement; Amendment. This Agreement, including any exhibits attached hereto and the provisions referenced in such Exhibits, sets forth the entire understanding and agreement of the parties and supersedes any and all oral or written agreements or understandings between the parties as to the subject matter of this Agreement. Any amendments or changes to this Agreement must be in writing and signed by both parties.
EXHIBIT A
HIPAA Business Associate Agreement
THIS HIPAA BUSINESS ASSOCIATE AGREEMENT (this “Business Associate Agreement”) between Practitioner (“Practitioner” or “Covered Entity”) and Bariatric Advantage, an operating division of Metagenics LLC, a Delaware limited liability company with offices at 25 Enterprise, Suite 200, Aliso Viejo, CA 92656 (“Bariatric Advantage” or “Business Associate”) is effective as of the same date as the effective date of that certain BARIATRIC ADVANTAGE ONLINE™ WEBPAGE AGREEMENT – RECOMMENDATION ESTORE between Practitioner and Bariatric Advantage (the “Effective Date”).
WHEREAS, Practitioner is disclosing and/or making available certain data, which may include Protected Health Information as that term is defined in 45 C.F.R. § 160.103, to Bariatric Advantage;
WHEREAS, Practitioner has requested that Bariatric Advantage enter into a business associate agreement;
WHEREAS, Bariatric Advantage is willing, given its commitment to privacy and security protections, to sign a business associate agreement with Practitioner;
WHEREAS, Practitioner is or may be subject to the requirements of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and privacy and security regulations promulgated thereunder (45 C.F.R. Parts 160 and 164) (the “Privacy Regulations” and the “Security Regulations”);
WHEREAS, Practitioner and Bariatric Advantage seek to comply with those provisions under Subtitle D (Privacy) of the Health Information Technology for Economic and Clinical Health Act of 2009 (“HITECH”) that apply to covered entities and business associates, respectively; and
WHEREAS, Bariatric Advantage shall use Practitioner’s Protected Health Information as mutually agreed by the Parties (“the Activities”);
NOW, THEREFORE, the parties agree as follows:
Definitions.
A. Catch-all 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.
B. Specific definitions.
“Business Associate” shall generally have the same meaning as the term “business associate” at 45 C.F.R. § 160.103 and, in reference to the party to this Agreement, shall mean Bariatric Advantage, an operating division of Metagenics LLC.
“Covered Entity” shall generally have the same meaning as the term “covered entity” at 45 C.F.R. § 160.103 and, in reference to the party to this Agreement, shall mean Practitioner.
“HIPAA Rules” shall mean the Privacy, Security, Breach Notification, and Enforcement Rules at 45 C.F.R. Part 160 and Part 164.
II. Obligations and Activities of Business Associate.
Business Associate agrees to:
Not use or disclose Protected Health Information other than as permitted or required by this Agreement or as Required By Law;
Use appropriate safeguards, and comply with Subpart C of 45 C.F.R. Part 164 with respect to electronic Protected Health Information, to prevent use or disclosure of Protected Health Information other than as provided for by this Agreement;
Report to Covered Entity any use or disclosure of Protected Health Information not provided for by this Agreement of which it becomes aware, including Breaches of Unsecured Protected Health Information as required at 45 C.F.R. § 164.410, and any Security Incident of which it becomes aware;
In accordance with 45 C.F.R. §§ 164.502(e)(1)(ii) and 164.308(b)(2), if applicable, ensure that any Subcontractors that create, receive, maintain, or transmit Protected Health Information on behalf of Business Associate agree to the same restrictions, conditions, and requirements that apply to Business Associate with respect to such information;
Make available Protected Health Information in a Designated Record Set to Covered Entity as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.524;
Make any amendment(s) to Protected Health Information in a Designated Record Set as directed or agreed to by Covered Entity pursuant to 45 C.F.R. § 164.526, or take other measures as necessary to satisfy Covered Entity’s obligations under 45 C.F.R § 164.526;
Maintain and make available the information required to provide an accounting of disclosures to Covered Entity as necessary to satisfy Covered Entity’s obligations under 45 C.F.R. § 164.528;
To the extent Business Associate is to carry out one or more of Covered Entity’s obligation(s) under Subpart E of 45 C.F.R. Part 164, comply with the requirements of Subpart E that apply to Covered Entity in the performance of such obligation(s); and
Make its internal practices, books, and records available to the Secretary for purposes of determining compliance with the HIPAA Rules.
III. Permitted Uses and Disclosures by Business Associate.
A. Business Associate may only use or disclose Protected Health Information as required to satisfy its obligations to perform the Activities or as otherwise permitted herein.
B. Business Associate is authorized to use Protected Health Information to de-identify the information in accordance with 45 C.F.R. § 164.514(a)-(c).
C. Business associate may use or disclose Protected Health Information as Required By Law (as that term is defined in 45 C.F.R. § 164.103).
D. Business Associate agrees to make uses and disclosures and requests for Protected Health Information, consistent with the Minimum Necessary requirement, as applicable.
E. Business Associate may not use or disclose Protected Health Information in a manner that would violate Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, except for the specific uses and disclosures set forth below in paragraphs F, G, H, and I of this Section III (“Permitted Uses and Disclosures”).
F. Business Associate may use Protected Health Information to contact patients and offer such patients an authorization for the use and disclosure of Protected Health Information that complies with 45 C.F.R. § 164.508. If a patient chooses to sign such an authorization, Business Associate may use and disclose Protected Health Information to the extent permitted by the authorization, including to market Business Associate’s products.
G. Business Associate may use Protected Health Information for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate.
H. Business Associate may disclose Protected Health Information for the proper management and administration of Business Associate or to carry out the legal responsibilities of Business Associate, provided the disclosures are Required By Law, or Business Associate obtains reasonable assurances from the person to whom the information is disclosed that the information will remain confidential and used or further disclosed only as Required By Law or for the purposes for which it was disclosed to the person, and the person notifies Business Associate of any instances of which it is aware in which the confidentiality of the information has been Breached.
I. Business Associate may perform Data Aggregation activities relating to the Health Care Operations of Covered Entity.
IV.Provisions for Covered Entity to Inform Business Associate of Privacy Practices and Restrictions.
A. 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 Protected Health Information.
B. 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 Protected Health Information, to the extent that such changes may affect Business Associate’s use or disclosure of Protected Health Information.
C. Covered Entity shall notify Business Associate of any restriction on the use or disclosure of Protected Health Information 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 Protected Health Information.
V. Permissible Requests by Covered Entity. Covered Entity shall not request Business Associate to use or disclose Protected Health Information in any manner that would not be permissible under Subpart E of 45 C.F.R. Part 164 if done by Covered Entity, provided, however, that this restriction shall not apply for uses or disclosures of Protected Health Information for Data Aggregation activities performed by Business Associate or for the management and administration and legal responsibilities of Business Associate.
VI. Term and Termination.
A. Term. The Term of this Agreement shall be effective as of the Effective Date, and shall terminate when Business Associate has completed performance of the Activities or when either party terminates for cause as authorized in paragraph B of this Section VI (“Term and Termination”), whichever is sooner.
B. Termination for Cause. Business Associate authorizes termination of this Agreement by Covered Entity, if Covered Entity determines Business Associate has violated a material term of this Agreement and Business Associate has not cured the violation or ended the violation within the time reasonably specified by Covered Entity. Covered Entity likewise authorizes termination of this Agreement by Business Associate, if Business Associate determines Covered Entity has violated a material term of this Agreement and Covered Entity has not cured the violation or ended the violation within the time reasonably specified by Business Associate.
C. Obligations of Business Associate upon Termination. Upon termination of this Agreement for any reason, Business Associate, with respect to Protected Health Information received from Covered Entity, or created, maintained, or received by Business Associate on behalf of Covered Entity, shall:
Retain only that Protected Health Information which is necessary for Business Associate to continue its proper management and administration or to carry out its legal responsibilities;
Return to Covered Entity or, if agreed to by Covered Entity, destroy the remaining Protected Health Information that Business Associate still maintains in any form;
Continue to use appropriate safeguards and comply with Subpart C of 45 C.F.R. Part 164 with respect to electronic Protected Health Information to prevent use or disclosure of the Protected Health Information, other than as provided for in this Section, for as long as Business Associate retains the Protected Health Information;
Not use or disclose the Protected Health Information retained by Business Associate other than for the purposes for which such Protected Health Information was retained and subject to the same conditions set out at paragraphs F, G, H, and I of Section III (“Permitted Uses and Disclosures”), which applied prior to termination; and
Return to Covered Entity or, if agreed to by Covered Entity, destroy the Protected Health Information retained by Business Associate when it is no longer needed by Business Associate for its proper management and administration or to carry out its legal responsibilities.
D. Survival. The obligations of Business Associate under this Section shall survive the termination of this Agreement.
VII. Miscellaneous.
A. Regulatory References. A reference in this Agreement to a section in the HIPAA Rules means the section as in effect or as amended.
B. Amendment. The Parties agree to take such action as is necessary to amend this Agreement from time to time as is necessary for compliance with the requirements of the HIPAA Rules and any other applicable law.
C. Interpretation. Any ambiguity in this Agreement shall be interpreted to permit compliance with the HIPAA Rules.
D. Notices. All notices required or permitted by this Agreement shall be in writing and shall be directed to the appropriate party at its address set forth above or such other address as a party may, from time to time, designate by written notice to the other party.
