MedGrid, LLC or Skydell Medical, LLC and Pharmacy
This Pharmacy Services and Supply Agreement (this "Agreement") is entered into as of June 10, 2026 (the "Effective Date") by and between Skydell Medical, LLC, a Delaware limited liability company ("Company"), and ____________________, a licensed pharmacy ("Pharmacy"). Company and Pharmacy are each a "Party" and together the "Parties." [Confirm which entity contracts with the Pharmacy; the distributor and 503B analysis differs depending on the entity and the order flow.]
Company operates or supports a platform through which licensed prescribers submit patient-specific prescriptions. The Pharmacy wishes to provide compounding and dispensing services for prescriptions routed through the platform. The Parties agree as follows:
The Pharmacy shall compound and dispense patient-specific prescriptions transmitted through the platform, in compliance with this Agreement and applicable law. The Pharmacy shall dispense only pursuant to a valid prescription for an individually identified patient issued by a prescriber authorized to order through the platform.
2.1 503A Compounding. The Pharmacy represents that its compounding under this Agreement qualifies for the exemptions of Section 503A of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. Section 353a), is performed pursuant to a valid patient-specific prescription, and complies with USP Chapters 795, 797, and 800. The Pharmacy shall not engage in anticipatory compounding or office-stock distribution beyond the limits permitted by Section 503A, and shall not use the platform to distribute compounded products other than pursuant to patient-specific prescriptions. [If the Pharmacy intends to provide office-stock or non-patient-specific product, a separate 503B outsourcing-facility arrangement and FDA registration are required.]
2.2 No Copies of Commercial Products. The Pharmacy shall not compound a product that is essentially a copy of a commercially available drug except as permitted by law, and shall not compound any drug on the FDA list of products that present demonstrable difficulties for compounding or that has been withdrawn or removed for safety reasons.
2.3 Licensure and Permits. The Pharmacy represents and warrants that it holds, and shall maintain, all licenses, registrations, and nonresident pharmacy permits required in each state to or in which it compounds, dispenses, or ships, and a current DEA registration to the extent it handles controlled substances. The Pharmacy shall provide evidence of such licensure on request and shall notify Company promptly of any lapse, restriction, investigation, or disciplinary action.
2.4 Inspections and Findings. The Pharmacy shall notify Company of any FDA Form 483, Warning Letter, state board action, recall, or import alert affecting products dispensed through the platform, promptly after receipt.
3.1 Quality. The Pharmacy shall maintain quality and testing procedures appropriate to the products compounded and shall provide a certificate of analysis or equivalent documentation on request.
3.2 Recall. In the event of a recall or safety alert, the Pharmacy shall immediately notify Company, cooperate in the recall, and bear the costs associated with a recall arising from the Pharmacy's product or conduct.
3.3 Adverse Events. The Pharmacy shall notify Company within twenty-four (24) hours of any adverse event of which it becomes aware relating to a product dispensed through the platform, and shall comply with applicable reporting obligations.
Pricing and payment terms are set forth in Exhibit A. Pricing and payment terms are set forth in the applicable order form or statement of work executed by the parties. All fees represent fair market value for the services and products provided, are negotiated at arm's length, and are not determined in any manner that takes into account the volume or value of referrals or of business otherwise generated between the Parties.
To the extent either Party creates, receives, maintains, or transmits protected health information on behalf of the other, the Parties shall execute a Business Associate Agreement, which shall govern those obligations. Each Party shall comply with HIPAA and applicable state privacy law.
The Pharmacy shall maintain professional liability, general liability, and product liability insurance in commercially reasonable amounts, and shall name Company as an additional insured on its general and product liability policies, providing evidence on request.
Each Party represents that it is duly organized and authorized to enter into this Agreement, and that its performance complies with applicable law. The Pharmacy further represents that products compounded and dispensed will not be adulterated or misbranded and will conform to applicable standards.
The Pharmacy shall indemnify, defend, and hold harmless Company and its affiliates from and against claims arising out of the Pharmacy's compounding, dispensing, products, breach of this Agreement, or violation of law, including any product liability and any regulatory noncompliance.
This Agreement begins on the Effective Date and continues for an initial term of one (1) year, renewing for successive periods unless either Party gives notice of non-renewal at least thirty (30) days before the end of the then-current term. Either Party may terminate for the other Party's material breach not cured within thirty (30) days of written notice, and Company may terminate immediately upon any lapse of the Pharmacy's required licensure, any exclusion from a federal health care program, or any conduct creating material regulatory or safety risk.
This Agreement is governed by the laws of the State of Delaware, without regard to conflict of laws principles. Any dispute shall be resolved through good faith negotiation for thirty (30) days, then non-binding mediation administered by JAMS in Miami Beach, Florida, and then final and binding arbitration administered by JAMS before a single arbitrator in Miami Beach, Florida, with a waiver of jury trial and of class or representative proceedings, and a carve-out permitting either Party to seek injunctive relief. The prevailing Party is entitled to its reasonable attorneys' fees and costs. This Agreement, including its Exhibits, is the entire agreement on its subject matter, may be amended only in a writing signed by both Parties, and may not be assigned without the other Party's consent.
IN WITNESS WHEREOF, the Parties have executed this Agreement as of the Effective Date.
COMPANY: Skydell Medical, LLC
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Pricing, payment terms, and service-level terms are set forth in the applicable pricing schedule or purchase orders executed under this Agreement.