COMPOUNDING PRODUCT SOURCING TERMS AND CONDITIONS
These Compounding Product Sourcing Terms and Conditions ("Agreement") govern your (“you”, “your”, or “Provider”) obligations related to submitting prescription orders to New Vitalis, Inc. d/b/a New Vitalis Pharmacy ("Pharmacy") and making payment and receiving prescription orders on behalf of your patients (as applicable).
You accept this Agreement by providing your signature below.
The individual accepting this Agreement represents and warrants that such individual has the authority to enter into and bind Provider to this Agreement. If the individual reviewing this Agreement does not have such authority or if Provider does not agree with any of the terms of this Agreement, such individual must not accept this Agreement and such Provider must not submit prescription orders to Pharmacy.
PLEASE READ THIS AGREEMENT CAREFULLY BEFORE SUBMITTING PRESCRIPTION ORDERS. YOU ACKNOWLEDGE AND AGREE THAT THIS AGREEMENT HAS THE SAME FORCE AND EFFECT AS IF IT WERE EXECUTED IN A WRITTEN DOCUMENT BY YOU AND PHARMACY. BY PROVIDING YOUR SIGNATURE BELOW OR SUBMITTING A PRESCRIPTION ORDER, YOU: (A) ACKNOWLEDGE THAT YOU HAVE READ AND UNDERSTAND THIS AGREEMENT; (B) REPRESENT THAT YOU HOLD A VALID MEDICAL LICENSE IN EACH STATE IN WHICH YOU PROVIDE MEDICAL SERVICES; (C) POSSESS THE LEGAL RIGHT TO ENTER INTO A BINDING AGREEMENT; AND (D) ACCEPT WITHOUT LIMITATION CONDUCTING THIS TRANSACTION ELECTRONICALLY, DISCLAIMERS OF WARRANTIES, DAMAGE AND REMEDY EXCLUSIONS AND LIMITATIONS, ARBITRATION, AND CHOICE OF COMMONWEALTH OF KENTUCKY LAW. IF YOU DO NOT AGREE TO THIS AGREEMENT, THEN YOU HAVE NO RIGHT TO, AND SHALL NOT, ACCESS OR USE OUR PHARMACY SERVICES.
1. Product . Pursuant to the terms and conditions of this Agreement, Pharmacy agrees to provide the product(s) set forth on Exhibit A (“Products”) to Provider upon receipt of a Compounding Order (as defined below) from a Provider practitioner (“Practitioner”). For purposes of this Agreement, a Practitioner shall mean a licensed health care provider employed by or contracted with Provider and who is authorized to prescribe the Product under applicable state and/or federal law.
2. Product Ordering, Shipping, Returns and Recalls .
2.1 Compounding Orders . A Provider Practitioner (or his or her authorized designee) shall submit a prescription for Product (“Compounding Order”) to Pharmacy. All Compounding Orders shall be valid prescriptions under the laws of Commonwealth of Kentucky and the state in which Provider Practitioner is located. Pharmacy shall reject any Compounding Orders that are not “valid” under state law. Product specified in a Compounding Order will be compounded by Pharmacy upon: (1) Pharmacy’s acceptance of a patient-specific prescription order that is valid under applicable state law and is prescribed by a Provider Practitioner and (2) successful processing by Pharmacy of payment (the “Payment”) for the Product in accordance with Section 2.3 below.
2.2 Product Price, Payment & Processing . The price of the Product shall be the then-current price on the date Pharmacy accepts a Compounding Order from Provider (the “Product Price”). Exhibit A lists the Product Price as of the Effective Date of this Agreement. Pharmacy may adjust the Product Price and Product offerings at its discretion at any time by providing Provider email notice of pricing or other Product adjustments. All prices are exclusive of applicable taxes including, but not limited to, sales, use, and excise tax. For the avoidance of doubt, the Payment shall be inclusive of the Product Price and Delivery Fee as defined below. The Product Price represents fair market value in an arm’s length transaction and does not take into account the volume or value of referrals between the Parties. If Provider will make the payment for Product on the patient’s behalf, Pharmacy shall process the Payment via a Provider credit card kept on file in Pharmacy’s online secure payment processing system, in accordance with the terms of the Recurring Payment Authorization Form executed by Provider attached hereto as Exhibit B . If a Compounding Order is received and Pharmacy is, for any reason, unsuccessful in processing Payment for that specific Compounding Order in accordance with this Section, Pharmacy will not compound and ship Product associated with the Compounding Order until the Payment is received by Pharmacy.
2.3 Provider Billing & Collecting; No Mark Up . If Provider will make the payment for Product on the patient’s behalf, Provider shall be responsible for billing its patients under this Agreement to recoup the Payment processed by Pharmacy via the Provider credit card. Provider is required to make good faith efforts to obtain payment from its patients and shall not offer Products to patients for less than the amounts charged hereunder. Provider shall hold Pharmacy harmless for any failure to collect from patients. Additionally, when billing and collecting from its patients for Products under this Agreement, Provider shall not “mark up” the Product Price or Delivery Fee, but rather pass through the amount paid by Provider.
2.4 Shipping, Delivery Fee & Delivery Intervals . Pharmacy shall ship Product to Provider on behalf of its patient. By submitting a Compounding Order Provider represents and warrants that it has permission to accept deliver of Product on behalf of the patient. Title to and risk of loss of the Product shall pass to Provider when the Product is received by Provider personnel at Provider’s designated location. Provider shall be responsible for all shipping and packaging costs related to the delivery of the Product; Pharmacy shall pass through a fee equal to Pharmacy’s actual shipping and packaging costs (the “Delivery Fee”) to Provider. Pharmacy shall arrange for Product to be delivered upon a mutually agreeable timeline in accordance with Product stabilization requirements prior to a patient appointment involving the Product.
2.5 Shipment Inspections . Immediately upon receipt of Product, Provider shall visually inspect the Product and notify Pharmacy of any discrepancy in the order, shipment damage, or any visible defect (without the necessity of opening individual packaging) by giving written notice of the Compounding Order and any other necessary information to identify the shipment of Product. Provider shall not administer or provide patient with any Product that is defective.
2.6 Product Recall . Pharmacy shall notify Provider promptly of any recalls related to the Products initiated by Pharmacy, a pharmaceutical manufacturer, or the U.S. Food and Drug Administration (“FDA”). Provider shall cooperate in good faith with Pharmacy in the event of a Product recall.
3. Provider Use and Handling of Product.
3.1 Storage and Handling . Provider shall keep Product stock in good and safe condition. Provider shall strictly comply with the information set forth in product labeling and communications to Provider from Pharmacy with respect to storage, handling and shipment of Product and hold Pharmacy harmless for its failure to so comply. Provider shall be responsible for costs associated with storage and handling of Product from Pharmacy.
3.2 No Diversion . Provider shall not knowingly administer any expired, defective, adulterated or misbranded, or counterfeit Product. At Pharmacy’s cost, Provider will deliver any such diverted Product to Pharmacy upon reimbursement. If and when Provider has knowledge of any entity or person offering, selling or purchasing diverted Products, Provider shall promptly provide written notice to Pharmacy describing information concerning diverted Product.
3.3 Practitioners . Provider shall ensure that all Practitioners submitting Compounding Orders to Pharmacy under this Agreement have, and for the Term will maintain, all required (1) state licenses to practice the applicable profession and (2) to the extent applicable, state and federal narcotics and controlled substance numbers and licenses, without restriction or subject to any disciplinary or corrective action. Provider shall also ensure that Practitioners and other Provider personnel comply with storage and handling requirements as set forth in Section 3.1. Provider and its Practitioners shall be solely and exclusively responsible for determining the medical necessity and appropriateness of Product’s use in treatment of a particular patient.
4. Mutual Representations, Warranties, and Covenants.
4.1 Mutual Compliance with Law . The Parties agree to comply with all applicable laws (federal, state and local) connected with or related to the provision of Product, including storage, distribution, sale, or destruction of Products provided under this Agreement, including, but not limited to, the federal Anti-Kickback Statute (42 U.S.C. § 1320a-7b) (“AKS”), the Public Contracts Anti-Kickback Act (41 U.S.C. § 51 et seq.), the Food, Drug and Cosmetic Act (21 U.S.C. § 301 et seq) (“FDCA”), the Stark Law (42 U.S.C. § 1395nn), the Health Insurance Portability and Accountability Act of 1996, the Health Information Technology for Economic and Clinical Health Act, and their implementing regulations set forth at 45 C.F.R. Parts 160 and Part 164 (collectively, the “HIPAA Regulations”), the Drug Supply Chain Security Act (21 U.S.C. § 351 et seq) (“DSCSA”) , and any laws and regulations relating to the terms of this Agreement, as required. The Parties shall obtain and maintain all federal, state and local approvals, licenses, permits, and certifications required of their respective operations for performance of their obligations under this Agreement. Neither Party shall undertake any activities which contravene this subsection in the performance of this Agreement. Each Party shall notify the other, within ten (10) business days, of any suspension, revocation, condition, limitation, qualification, or other restriction on any such approval, license, permit, or certification which would impede that Party in the performance of its obligations under this Agreement.
4.2 Authority . Each Party represents and warrants that it has the authority to enter into this Agreement and that its execution of this Agreement and its performance of its obligations hereunder does not conflict with and is not prohibited by or inconsistent with any other agreement to which it is a party.
4.3 Independent Judgment . The Parties acknowledge this Agreement is not intended to usurp the independent professional and/or clinical decision-making of any Pharmacy employee or Provider Practitioner.
4.4 No Exclusion . Each Party (including, for Provider, its Practitioners) represents and warrants that it has never been, is not currently, and, during the Term of this Agreement will not become, a Debarred, Excluded, or Convicted Individual or Entity. For purposes of this Section, “Debarred Individual” is an individual who is debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) and 21 C.F.R. § 312.70 from providing services in any capacity to a person that has an approved or pending drug product application, or an employer, employee, or partner of a Debarred Individual; a “Debarred Entity” is a corporation, partnership, or association that is debarred by the FDA pursuant to 21 U.S.C. § 335a (a) or (b) and 21 C.F.R. § 312.70 from submitting or assisting in the submission of any abbreviated drug application, or an employee, partner, shareholder, member, subsidiary, or affiliate of a Debarred Entity; an “Excluded Individual” or “Excluded Entity” is an individual or entity, as applicable, who is excluded, debarred, or is otherwise ineligible to participate in: (i) federal health care programs, such as Medicare or Medicaid, by the Office of the Inspector General of the U.S. Department of Health and Human Services (“HHS”); or (ii) federal procurement and non-procurement programs, including those produced by the U.S. General Services Administration; and a “Convicted Individual” or “Convicted Entity” is an individual or entity, as applicable, who is convicted of a criminal offense that falls within the scope of 21 U.S.C. § 335a(a) or 42 U.S.C. § 1320a – 7(a). Each Party further warrants and represents that no Debarred Individual or Entity, Excluded Individual or Entity, or Convicted Individual or Entity will perform or render any obligations under the Agreement. Moreover, each Party covenants that in the event it or any of its employees or representatives are subsequently debarred under the FDCA or excluded from a federal health care program during the Term of this Agreement, it shall notify the other within five (5) business days.
5. Provider Representations, Warranties and Covenants. Provider represents and warrants that: (i) it shall only use Product for its own use or as otherwise permitted by “Dispensers” in accordance with the DSCSA; (ii) it shall not “mark up” the Product Price contemplated under this Agreement, but instead shall provide “pass through” Product Pricing to patients/end users of the Products; (iii) it shall not take any actions to impede the patient-pharmacist relationship between patients/end users and Pharmacy; (iv) it takes full responsibility for clinical care, prescribing decisions and monitoring of patients/end users of the Products administered under this Agreement; (v) it will comply with all Product storage and handling requirements communicated to Provider by Pharmacy as well as applicable laws, regulations, directives and requirements related to the Product from the FDA, and federal, state and local laws and rules, including without limitation, packaging and labeling requirements, Product warning requirements, Product design and safety requirements, and advertising requirements, and (vi) it will cause its Practitioners to comply with this Section 5 and other applicable provisions of this Agreement.
6. Confidentiality. “Confidential Information” means a ll confidential and proprietary information disclosed by one Party (the “Disclosing Party”) to the other Party (the “Receiving Party”) regardless of the means of communication, directly or indirectly, in writing, electronically, orally, by inspection of tangible objects, or whatever other form transmitted. Confidential Information includes, without limitation, information that is related to the following: the business, activities, customers, referral sources, service levels, or facilities of the Disclosing Party, product specifications, product plans, or any know-how, trade secrets, and other intellectual property that is disclosed to, observed or obtained under the Agreement. The Receiving Party shall (i) protect and safeguard Confidential Information with at least the same degree of care as the Receiving Party would protect its own Confidential Information, but in no event with less than a reasonable degree of care, to prevent disclosure to third parties; (ii) not use the Confidential Information disclosed by Disclosing Party, or permit it to be accessed or used, for any purpose other than to exercise its rights or perform its obligations under this Agreement; and (iii) not disclose the Disclosing Party’s Confidential Information to any person or entity, except to Disclosing Party’s employees and agents who need to know the Confidential Information in order to assist Receiving Party to exercise its rights or perform its obligations under this Agreement, and who are under an obligation of confidentiality no less restrictive than as set forth in this Agreement. The Receiving Party shall be responsible for any breach of this Section that may be caused by any of its employees or agents. Receiving Party shall promptly notify Disclosing Party of any unauthorized possession, use or disclosure, or attempt thereof, of the Confidential Information (“Confidentiality Breach”) and promptly furnish to Disclosing Party the details of such Confidentiality Breach and use reasonable efforts to assist Disclosing Party in investigating and preventing the recurrence of such Confidentiality Breach. The Parties’ obligations of confidentiality under this Agreement shall survive the termination or expiration of this Agreement, and shall be in addition to, and not in place of, any other non-disclosure and/or confidentiality obligations that the Parties may otherwise agree upon.
6.1 Exceptions. The limitations on use and the nondisclosure contained in this Agreement will not apply to the extent that: (i) the disclosure is required for accreditation or licensure, or for the performance of routine business operations; (ii) Receiving Party is required to disclose the Confidential Information by law, order, judicial process, or regulation of a court of competent jurisdiction, provided that Receiving Party will make a reasonable effort to provide, in accordance with applicable law, advance written notice of such requirement to Disclosing Party; or (iii) Receiving Party can demonstrate that (a) the information was public knowledge at the time of such disclosure, or thereafter became public knowledge, other than as a result of acts attributable to Receiving Party in violation of this Agreement; (b) the information was rightfully known by Receiving Party prior to the date of disclosure; (c) the information was disclosed to Receiving Party on an unrestricted basis by a third party not under a duty of confidentiality to such Party; or (d) the information was independently developed by employees or agents of Receiving Party without access to or use of the Confidential Information of Disclosing Party.
6.2 Remedies. Each Party acknowledges and agrees that money damages may not be a sufficient remedy for any Confidentiality Breach or threatened Confidentiality Breach of a Party’s Confidential Information by Receiving Party . Therefore, in addition to all other remedies available at law or pursuant to this Agreement (which neither Party waives by the exercise of any rights hereunder), Disclosing Party will be entitled to seek specific performance and injunctive and other equitable relief as a remedy for any such Confidentiality Breach or threatened Confidentiality Breach, and the Parties hereby waive any requirement for the securing or posting of any bond or the showing of actual monetary damages in connection with such claim.
6.3 Return or Destruction. Except as otherwise provided herein, on the expiration or termination of this Agreement, or at the written request of the Party that disclosed the Confidential Information, the Party that received the Confidential Information shall either promptly return to the Disclosing Party all copies, whether in written, electronic, or other form of media, of such Confidential Information, or destroy all such copies and provide written confirmation of such destruction. Notwithstanding, each Party may retain one (1) copy of the other Party’s Confidential Information for purposes of determining the Parties’ rights and obligations under this Agreement.
7. Audit. Term and Termination.
7.1 Agreement Term . This Agreement shall commence on the date accepted by Provider (“Effective Date”) and have a term of one (1) year from the Effective Date, and shall automatically renew for successive one-year (1-year) terms unless either Party sends a notice of non-renewal to the other Party at least ninety (90) days prior to the expiration of the term then in effect (“Term”).
7.2 Termination without Cause. Either Party may terminate this Agreement without cause upon ninety (90) days’ prior written notice to the other Party.
7.3 Termination for Cause . Either Party may terminate this Agreement upon the occurrence of a material breach by the other Party. The non-breaching Party must give written notice to the breaching Party of the nature and occurrence of such breach. If the breach is not cured within thirty (30) days of such notice, or if the breach cannot reasonably be cured within such thirty-day (30-day) period, then the non-breaching Party may provide written notice to the breaching Party that this Agreement will be terminated immediately. Notwithstanding the forgoing, either Party may effect an immediate termination of this Agreement upon notice to the other Party if the other Party: (i) shall be dissolved or apply for or consent to the appointment of a receiver, trustee or liquidator of all or a substantial part of its assets; (ii) files a voluntary petition in bankruptcy; (iii) admits in writing its inability to pay its debts as they become due; (iv) makes a general assignment for the benefit of creditors; (v) files a petition or an answer seeking reorganization or arrangement with creditors or taking advantage of any insolvency law; or (vi) if an order, judgment or decree shall be entered by a court of competent jurisdiction, on the application of a creditor, adjudicating such Party as bankrupt or insolvent or approving a petition seeking reorganization of such Party or appointing a receiver, trustee or liquidator of such Party of all or a substantial part of its assets. Termination shall have no effect upon the rights or obligations of the Parties arising out of any transactions occurring prior to the effective date of such termination.
8. Indemnification.
8.1 Provider’s Indemnification Obligation . Provider will defend, indemnify, and hold harmless Pharmacy and its parent company, subsidiaries, members, directors, officers, employees and representatives from and against any and all third-party claims, liabilities, losses, damages, costs, and expenses (including reasonable attorneys’ fees) arising directly or indirectly out of: (i) the use of a Product by a patient/end-user; (ii) Provider’s breach of any representation or warranty set forth in this Agreement; (iii) the alleged fraud, intentional misconduct, omission or negligence of Provider; or (iv) Provider’s violation of applicable law. However, Provider’s indemnity obligations shall not extend to any claims arising solely from the negligence or willful misconduct of, or any violation of applicable law by, Pharmacy.
8.2 Pharmacy's Indemnification Obligation . Pharmacy will defend, indemnify, and hold harmless Provider and its subsidiaries, members, directors, officers, employees, and representatives from and against any and all third-party claims, liabilities, losses, damages, costs, and expenses (including reasonable attorneys’ fees) arising directly or indirectly out of: (i) its breach of any representation or warranty set forth in this Agreement; (ii) the fraud, intentional misconduct, or negligence of Pharmacy; or (iii) any violation of applicable law. However, Pharmacy's indemnity obligations shall not extend to any claims arising solely from the negligence or willful misconduct of Provider.
8.3 LIMITATION OF LIABILITY . EXCEPT FOR THE PARTIES’ INDEMNITY OBLIGATIONS, NEITHER PARTY SHALL BE LIABLE TO THE OTHER FOR ANY SPECIAL, INCIDENTAL, CONSEQUENTIAL, INDIRECT OR PUNITIVE DAMAGES ARISING OUT OF OR RELATING TO THIS AGREEMENT.
9. Insurance. Provider shall maintain in effect during the Term of this Agreement a comprehensive general liability policy underwritten by an insurance company that carries an A- or better rating from A.M. Best. This comprehensive insurance policy shall be in an amount not less than one million dollars ($1,000,000) per occurrence. Provider shall provide thirty (30) days’ notice to the other Party in the event of any cancellation or termination thereof. The amount of such required insurance coverage under this Section shall not limit Provider’s obligations under this Agreement.
10. Miscellaneous.
10.1 Amendment . This Agreement may only be amended, modified or supplemented by an agreement in writing signed by both Parties. No waiver by a Party of any of the provisions hereof shall be effective unless explicitly set forth in writing and signed by the Party so waiving. Except as otherwise set forth in this Agreement, no failure to exercise, or delay in exercising, any rights, remedy, power or privilege arising from this Agreement shall operate or be construed as a waiver thereof nor shall any single or partial exercise of any right, remedy, power or privilege hereunder preclude any other or further exercise thereof or the exercise of any other right, remedy, power or privilege.
10.2 Assignability . Except as specifically provided herein, this Agreement, or any of the rights or obligations created herein, may not be assigned, in whole or in part, by either Party without the prior written consent of the other Party; provided that Pharmacy may assign to a corporation or other business entity which at any time, whether by purchase, merger or otherwise, directly or indirectly acquires all or substantially all of the assets, voting rights, or business of the Provider.
10.3 Construction, Modification and Waiver . If any of the provisions of this Agreement are held void or unenforceable, the remaining provisions shall nevertheless be effective, the intent being to effectuate this Agreement to the fullest extent possible. Any headings contained herein are for directory purposes only, do not constitute a part of this Agreement, and shall not be employed in interpreting this Agreement. Any modification of this Agreement shall be in writing and shall be signed by authorized representatives of both Parties. Any attempt to modify this Agreement orally or in writing not executed by an authorized representative of both Parties hereto shall be void. A waiver of any breach of any provision of this Agreement shall not be construed as a continuing waiver of other breaches of the same or other provisions of this Agreement.
10.4 Complete Agreement . As of the Effective Date, this Agreement and any other agreements mentioned herein represent the entire agreement between the Parties with respect to the subject matter hereof. There are no understandings, representations or warranties of any kind except as expressly set forth herein.
10.5 Counterparts . This Agreement may be executed in two or more counterparts, each of which will be an original and, when taken together, constitute one and the same agreement.
10.6 Force Majeure . The performance by either Party hereunder shall be excused to the extent of circumstances beyond such Party’s reasonable control, such as hurricane, tropical storm or depression, extended power outages, flood, tornado, earthquake, volcano, or other natural disaster, epidemic, pandemic, war, acts of terrorism, material destruction of facilities, fire, acts of God, etc. In such event, the Parties agree to use their best efforts to resume performance as soon as reasonably possible under the circumstances giving rise to the Party’s failure to perform, provided, however, if performance is not restored within thirty (30) days, either Party may terminate this Agreement.
10.7 Governing Law . This Agreement shall be governed by, construed and interpreted under and in accordance with the laws of the Commonwealth of Kentucky, excluding its conflicts-of-laws principles. If legal action is required to enforce this Agreement, venue shall lie in Jefferson County, Commonwealth of Kentucky, or in the United States District Court for the Western District of Commonwealth of Kentucky.
10.8 Non-Exclusivity . The Parties mutually agree that this Agreement is non-exclusive and that each Party is free to contract and deal with other parties. However, neither Party shall, during the Term, enter into any agreement which will cause it to be in breach or default or conflict with its obligations under this Agreement.
10.9 Notices . Any notices to be given by either Party to the other shall be in writing and may be transmitted either by electronic mail, courier, personal delivery or by registered or certified mail (postage prepaid with return receipt requested). Mailed notices shall be addressed to the Parties at the addresses appearing in this paragraph. Each Party may change its address by written notice in accordance with this Section. Notices shall be deemed communicated as of the date of actual receipt (which, in the case of mailed notices, shall be evidenced by a delivery receipt).
Pharmacy: New Vitalis Pharmacy, 4139 Cadillac Ct., Suite 201, Louisville, KY 40213
Provider: At the address or email provided to Pharmacy in Provider’s online enrollment form
10.10 Relationship of the Parties . The Parties are independent contractors. Nothing herein contained shall be deemed to create a joint venture, agency or partnership relationship between the Parties. Neither Party shall have any power to enter into any contracts or commitments in the name of, or on behalf of, the other Party, or to bind the other Party in any respect whatsoever.
10.11 Survival . Unless otherwise expressly provided herein, only Sections 6, 8, and 10 shall survive the termination or expiration of this Agreement, as the case may be.
EXHIBIT A
PRODUCTS & PRICING As of the Agreement Effective Date*
*Pharmacy may adjust the Product Price and Product offerings upon email notice to Provider.