Appendix C: Draft API Supply Agreement

# Appendix C: Draft API Supply Agreement

INSTRUCTIONS FOR ATTORNEY REVIEW

This template is for sourcing active pharmaceutical ingredients (APIs) used in compounding. It should be used only with FDA-registered suppliers who can document the regulatory status of their APIs. Confirm with counsel that API supply is appropriately structured as a raw materials purchase rather than a product distribution. ---

ACTIVE PHARMACEUTICAL INGREDIENT SUPPLY AGREEMENT

This Active Pharmaceutical Ingredient Supply Agreement ("Agreement") is entered into as of [DATE] by and between: [BUYER NAME], a [STATE] [ENTITY TYPE] ("Buyer"), and [SUPPLIER NAME], a [STATE/COUNTRY] [ENTITY TYPE] with principal offices at [ADDRESS] ("Supplier"). ---

RECITALS

WHEREAS, Buyer operates or facilitates a pharmacy or clinical practice that compounds peptide medications; WHEREAS, Buyer wishes to purchase active pharmaceutical ingredients ("APIs") from Supplier for use in lawful compounding under Section 503A or 503B of the FD&C Act; WHEREAS, Supplier wishes to supply APIs to Buyer for the purpose described herein; NOW, THEREFORE, the Parties agree as follows: ---

ARTICLE 1: PURPOSE AND REGULATORY STATUS

1.1 Purpose. Buyer is purchasing APIs for use in lawful pharmaceutical compounding. This Agreement does not constitute a distribution agreement for finished drug products. Buyer is not a drug distributor and is not acquiring title to FDA-approved drug products for resale. 1.2 Regulatory Status. Supplier represents and warrants that the APIs supplied under this Agreement are sold for use in legitimate pharmaceutical compounding under Section 503A or 503B of the FD&C Act, and that the APIs are not FDA-approved drug products being introduced into a commercial distribution chain. 1.3 No Label Transfer. Buyer shall not remove, alter, or transfer any supplier labels, certificates, or documentation provided with the APIs. ---

ARTICLE 2: PRODUCTS AND SPECIFICATIONS

2.1 Products. The APIs to be supplied under this Agreement are listed in Exhibit A, as amended from time to time by mutual written agreement. 2.2 Specifications. Each API shall meet the specifications set forth in Exhibit B ("Specifications"). No API shall be deemed to meet Specifications unless it has passed all testing described in Exhibit B. 2.3 Certificate of Analysis. Each shipment of API shall be accompanied by a Certificate of Analysis (COA) from the manufacturer of the API, documenting that the API meets the Specifications. Buyer shall have the right to verify COA results through independent testing at Buyer's expense. ---

ARTICLE 3: ORDERING AND DELIVERY

3.1 Orders. Buyer shall submit purchase orders specifying the APIs, quantities, and requested delivery dates. Orders shall be confirmed by Supplier within [3] business days. 3.2 Minimum Orders. [Insert minimum order quantities if applicable] 3.3 Delivery. Supplier shall deliver AP用水 to Buyer's designated facility. Risk of loss and title shall pass to Buyer upon delivery to the designated facility. Buyer shall inspect shipments upon receipt. 3.4 Storage. Buyer shall store APIs in accordance with labeled storage conditions and applicable USP requirements. Buyer shall maintain records of storage conditions. ---

ARTICLE 4: TESTING AND ACCEPTANCE

4.1 Receipt Testing. Within [10] days of receipt, Buyer may conduct independent testing to verify that APIs meet Specifications. If API fails to meet Specifications, Buyer may reject the shipment by written notice within the testing period. 4.2 Rejection. If API is rejected, Supplier shall, at Buyer's option: (a) replace the rejected API at no cost; or (b) refund the purchase price. Supplier shall bear all costs of return shipping. 4.3 No Liability for Proper Use. Supplier's liability for APIs supplied under this Agreement is limited to replacement or refund as described above. Supplier shall have no liability for any injury or damage resulting from the proper use of APIs in compounding. ---

ARTICLE 5: REGULATORY REPRESENTATIONS

5.1 Supplier Representations. Supplier represents and warrants that: - (a) Each API is manufactured in a facility registered with FDA (if subject to registration); - (b) Each API is accompanied by a valid COA from a qualified testing laboratory; - (c) Supplier has not received any FDA warning letters or enforcement actions related to the APIs; - (d) The APIs are sold for lawful compounding purposes; and - (e) All representations regarding regulatory status are accurate and complete. 5.2 Buyer Representations. Buyer represents and warrants that: - (a) APIs purchased under this Agreement will be used in lawful pharmaceutical compounding under Section 503A or 503B; - (b) Buyer holds all required licenses and registrations for compounding; and - (c) Buyer is not a drug distributor. ---

ARTICLE 6: RECALLS

6.1 Notification. Supplier shall notify Buyer immediately upon learning of any recall, market withdrawal, or safety concern related to any API supplied under this Agreement. 6.2 Cooperation. The Parties shall cooperate in the event of a recall. ---

ARTICLE 7: FEES AND PAYMENT

7.1 Pricing. API pricing shall be as set forth in Exhibit C. 7.2 Invoicing and Payment. [Insert payment terms] ---

ARTICLE 8: CONFIDENTIALITY

[Insert confidentiality provisions] ---

ARTICLE 9: TERM AND TERMINATION

9.1 Term. [Insert term] 9.2 Termination. [Insert termination provisions] ---

ARTICLE 10: INDEMNIFICATION

10.1 Supplier Indemnification. Supplier shall indemnify Buyer for losses arising from Supplier's breach of its representations, negligence, or willful misconduct, or from any claim that the APIs as supplied infringe third-party IP rights. 10.2 Limitation. Supplier's total liability under this Agreement shall not exceed [the total fees paid by Buyer in the preceding 12 months]. ---

SIGNATURE PAGE

[BUYER NAME] By: _________________ Name: _______________ Title: _______________ Date: _______________ [SUPPLIER NAME] By: _________________ Name: _______________ Title: _______________ Date: _______________ ---

EXHIBIT A: Products (APIs)

[To be completed — list specific peptides, CAS numbers where applicable, forms]

EXHIBIT B: Specifications and Testing Requirements

[To be completed — specific test methods, acceptance criteria, testing frequency]

EXHIBIT C: Pricing

[To be completed — price per gram/unit, volume pricing, payment terms] --- *END OF APPENDIX C*