ORIGINAL ISSUE 1/1/2019
REVISED 1/1/2025
REVISION #2 9/24/2025
REVISION #3 1/13/2026
MANUFACTURING TERMS & CONDITIONS
GENERAL INFORMATION: Nutrition Laboratories operates a product development laboratory and beverage bottling facility in Clearwater, Florida, developing and co‑packing beverages and liquid dietary supplements (the “Products”). This document sets forth the terms, conditions, and obligations under which Nutrition Laboratories will produce Products for a customer (the “Customer”).
1. GENERAL TERMS AND CONDITIONS
Nutrition Laboratories shall perform its services in accordance with its Current Good Manufacturing Practices (“cGMPs”). Charges for services shall be based on a day fee, a per‑bottle co‑packing rate, or as otherwise agreed in writing with the Customer. Nutrition Laboratories shall email the Customer a written proposal (the “Proposal”) describing the services to be performed. Customer shall pay a minimum down payment of fifty percent (50%), which constitutes acceptance of the Proposal. The remaining balance shall be due and payable as set forth in the Proposal. Nutrition Laboratories shall issue a final invoice upon completion of each job.
2. FORMULA OWNERSHIP
Formulations provided by Customer are the property of Customer. Formulations developed by Nutrition Laboratories and paid for in full by Customer are the property of Customer. Nutrition Laboratories shall keep all Customer‑owned formulations confidential. Formulations developed by Nutrition Laboratories and not paid for by Customer remain the property of Nutrition Laboratories. Any changes or alterations made by Nutrition Laboratories to a Customer‑owned formulation at Customer’s request shall not grant Nutrition Laboratories any ownership interest in such formulation.
3. PROCESS AUTHORITY AND FDA NOTIFICATION
Where applicable, Nutrition Laboratories shall obtain a Process Authority Letter for the manufacture of the Products and shall submit any required process filings or notifications with the U.S. Food and Drug Administration (“FDA”).
4. PROCUREMENT BY CUSTOMER
Unless otherwise agreed in writing, Customer shall be responsible for procuring all ingredients and components used in the manufacture of the Products. Customer warrants that all such items conform to the specifications in the Product’s Master Formula and are fit for their intended use. Customer shall provide Nutrition Laboratories with current Certificates of Analysis (“COAs”) and Safety Data Sheets (“SDSs”) for each Customer‑supplied ingredient.
5. PROPRIETARY BLENDS SUPPLIED BY CUSTOMER
IIf Customer supplies a proprietary blend, Customer represents and warrants that all ingredients contained therein are safe, lawful, and approved for human consumption. Customer further represents that the identity and potency of such ingredients are accurately stated on the applicable COA and agrees to hold Nutrition Laboratories harmless from any deficiency, inaccuracy, or non‑compliance related to such blend.
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8. PRODUCT LABELS
Customer shall provide all product labels. Prior to printing, labels must be verified for size and FDA labeling compliance by Nutrition Laboratories. Nutrition Laboratories’ Director of Quality Control must review and approve all labels, including revisions to existing labels, prior to printing. Customer is solely responsible for regulatory compliance of all labels, including claims, representations, and marketing statements. Nutrition Laboratories may provide Nutrition Facts or Supplement Facts panels at no charge and may provide referrals to label printers.
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10. ORGANIC CERTIFICATION
II Customer requests organic certification, Nutrition Laboratories shall prepare the organic product calculation, assemble required documentation, and submit such materials to its organic certifier. The annual fee is $650 per product, due upon initial certification and each July 1 thereafter.
11. LABELING WITH ORGANIC INGREDIENTS
For Products that are not certified organic but reference organic ingredients, labels must be approved by Nutrition Laboratories’ organic certifier prior to printing. Nutrition Laboratories’ Quality Director shall advise Customer regarding approval requirements.
12. PURCHASES BY NUTRITION LABORATORIES
If Customer requests that Nutrition Laboratories purchase ingredients or components on Customer’s behalf, Nutrition Laboratories shall submit purchase orders for Customer’s approval. Purchases will be made only after receipt of full payment from Customer. A logistics fee shall be added to such purchases.
13. CUSTOMER-PROVIDED INGREDIENTS AND COMPONENTS
All Customer‑provided ingredients, bottles, caps, labels, cartons, and other components must arrive at Nutrition Laboratories’ warehouse at least ten (10) business days prior to the scheduled production date, unless otherwise agreed in writing.
14. INGREDIENTS FOR A FIRST PRODUCTION
Ingredients for a first production run must arrive no fewer than fifteen (15) business days prior to the scheduled production date to allow time for laboratory samples, Process Authority review, and FDA process filing..
15. MISSING INGREDIENTS OR COMPONENTS
If Customer‑supplied ingredients or components do not arrive in time for scheduled production and Nutrition Laboratories cannot backfill the production slot, Nutrition Laboratories may charge a day fee for each cancelled production day. If Customer‑supplied labels do not arrive on time, Nutrition Laboratories may proceed with bottling without labels. Final payment shall be due once Products pass microbial testing. Labeling and pack‑out shall be scheduled when labels become available, and additional labor charges may apply.
16. LEAD TIMES
After acceptance of a Proposal by Customer and downpayment, Nutrition Laboratories and Customer Upon acceptance of the Proposal and receipt of the down payment, the parties shall mutually agree upon a production date. Customer shall ensure timely delivery of all ingredients and components in accordance with Sections 13 and 14.
17. MANUFACTURING
Nutrition Laboratories shall manufacture Products in accordance with its cGMPs and all applicable federal and Florida regulations, and in conformity with the Product’s Master Manufacturing Record.
17A. MATERIAL WASTE
Customer acknowledges that normal production processes may result in waste of materials, including ingredients, bottles, caps, and labels.
18. BATCH APPROVAL BY CUSTOMER
Customer or its authorized representative shall be present on the day of production to approve the batch prior to bottling. If Customer elects not to attend, Customer authorizes Nutrition Laboratories’ Director of Quality Control to approve the batch on Customer’s behalf, and agrees to accept such approval.
19. QUALITY ASSURANCE
Nutrition Laboratories shall monitor production and packaging in accordance with its Quality Assurance procedures. A microbial analysis and Certificate of Analysis for each batch are included in the co‑packing fee.
20. LOT NUMBER AND EXPIRATION DATE
Each production batch shall be assigned a lot number and Best‑By expiration date based on the Process Authority Letter and/or stability data. Alternatively, Products may be coded with a manufacturing date, as agreed.
21. PRODUCT HOLD
The first production batch of a new Product shall be held in quarantine for up to twenty‑one (21) days prior to release to verify microbial stability. Subsequent batches shall be quarantined for forty‑eight (48) hours for hot‑fill Products or seven (7) calendar days for cold‑fill Products..
22. TRIAL PRODUCTION
Nutrition Laboratories recommends a trial production run for new formulations lacking a documented history of commercial stability.
23. PACK OUT
Products shall be labeled, packed, and palletized per Customer instructions. Bulk pallet pack‑out labor is included in the co‑packing fee. Secondary packaging labor (e.g., display cartons or unit boxes) shall be quoted separately. Stickers for trays, cases, or pallets may be produced at Customer’s expense.
24. AMAZON STICKERS
Customer must notify Nutrition Laboratories in advance if Products are intended for Amazon fulfillment and must supply all required Amazon‑specific labels and stickers prior to palletizing.
25. PRODUCTION YIELDS
Customer acknowledges that finished unit quantities may vary from estimates due to normal manufacturing variation. Customer agrees to accept actual production yields. Per‑bottle charges shall apply only to bottles produced.
26. DELIVERY
Products shall be delivered FOB Nutrition Laboratories’ warehouse in Clearwater, Florida. Customer shall arrange pickup within five (5) business days of notice of availability. Nutrition Laboratories shall load trucks at its dock but is not obligated to arrange multi‑destination shipments unless agreed in writing.
27. WAREHOUSE STORAGE
Nutrition Laboratories provides complimentary storage for ingredients and components received up to four (4) weeks before production and for finished Products for two (2) weeks after completion. For repeat Customers, storage of ingredients and components may be provided for up to three (3) months, provided they are used within that period.
28. DISCARDING OF MATERIALS
Nutrition Laboratories may discard Products, ingredients, labels, or components not claimed within ninety (90) days after the most recent production. Customer shall bear all disposal costs.
29. EXPIRED INGREDIENTS
Nutrition Laboratories shall discard any Customer‑supplied ingredients that have exceeded their expiration date.
30. PRODUCT LIABILITY INSURANCE
Nutrition Laboratories shall maintain product liability insurance with a minimum aggregate limit of $2,000,000.
31. CLAIMS, AND SALE AND DISTRIBUTION
Customer is solely responsible for all labeling, advertising, and marketing claims, and for compliance with all laws governing sale and distribution of the Products. Customer shall indemnify and hold Nutrition Laboratories harmless from all claims arising therefrom..
32. STORAGE AND HANDLING OF PRODUCT BY CUSTOMER
Customer acknowledges that Product stability depends on proper storage and handling and that damage to closures or improper handling may compromise microbial integrity.
33. INSPECTION
Customer shall inspect Products within thirty (30) days of receipt. If Customer determines in good faith that all or a portion of the Products are non-conforming, Customer shall give written notice to Nutrition Laboratories with the reasons for the rejection. Nutrition Laboratories obligation to remedy such defective products will not begin until such dispute is resolved, Nutrition Laboratories will have ninety (90) days after the receipt of the returned Products to remedy any defects. If Nutrition Laboratories disagrees with such rejection, it has 15 days from receipt of such rejection to dispute it. Such a dispute will follow the guidelines set out by Section 36.
34. CONSEQUENTIAL DAMAGES
Except for insured product liability claims, Nutrition Laboratories’ liability is limited to replacement of confirmed defective Products. Nutrition Laboratories shall not be liable for consequential or incidental damages.
35. CLAIM LIMITATIONS
Any claim arising under this Agreement must be brought within ninety(90) days after the claim arises or is discovered, whichever is later.
36. DISPUTE RESOLUTION
Both parties agree to make a good-faith effort to resolve any dispute or claim through negotiation. If the parties are not able to resolve their differences, the parties agree to submit the dispute to mutually-agreed third-party Mediation. The venue for any mediation shall be Pinellas County, Florida. The cost of the Mediation shall be shared equally. If Mediation does not resolve the dispute, the parties agree to submit the claim or dispute for binding arbitration to be conducted by one certified arbitrator under rules and auspices of the American Arbitration Association or such other alternative dispute-settling forum approved in writing by both parties. The venue for any arbitration shall be Pinellas County, Florida. The arbitrator shall be empowered to allow discovery and decide claims subject only to the limitations set forth in this Agreement. The decision of the arbitrator and damages or equitable relief provided therein may be entered as a judgment in any court of competent jurisdiction. The cost of the Mediation shall be shared equally. Both parties agree to pay its own attorney fees for mediation and arbitration regardless of the outcome of such mediation and arbitration.
37. FORCE MA JEURE
Neither party shall be liable for failure or delay caused by events beyond its reasonable control, including acts of God, governmental actions, labor disruptions, equipment failure, or pandemics.
38. NOT A JOINT VENTURE
Nothing herein creates a partnership, joint venture, or agency relationship.
39. ABANDONMENT OF PRODUCTION
If Customer abandons a scheduled production, all payments received shall be forfeited.
40. PAYMENT DELAYS
If final payment is delayed, future productions may require full payment in advance.
41. CONFIDENTIALITY
Nutrition Laboratories and Customer acknowledge that in the performance of the terms and conditions in this document, each party may obtain information from the other party deemed confidential. Nutrition Laboratories and Customer will identify in writing to the other party all information deemed confidential and the recipient thereof will not use or disclose such information except to employees with a need to know in order to accomplish the purposes of this Agreement or to a government agency as required by law. Information shall not be deemed confidential if such information: (i) was in the public domain at the time of disclosure to the recipient, (ii) subsequently becomes available to the public without act or negligence of the recipient, (iii) can demonstrably be shown to have been in the recipient’s possession prior to its receipt from the other party, or (iv) is subsequently obtained by recipient from an independent third party having a lawful right to disclose the information.
42. ASSIGNMENTS
Any obligation described in this document may be assigned by either party only with the prior written consent of the other party, providing that such consent shall not be unreasonably withheld. A change in controlling ownership of either party shall not be deemed as assignment unless such change has a material adverse impact on the party’s ability to perform its obligations described in this document. Either party experiencing a change in controlling ownership shall provide written notice to the other party immediately upon its occurrence.
43. WARRANTIES
Each party warrants to the other party that it is duly organized and in good standing in its respective jurisdiction of organization, that it has the authority to perform the obligations described in this document and that those obligations will not violate any agreement or judicial order to which it is a party or by which it is bound. Except as expressly set forth herein, the parties make no other warranties and hereby disclaim all other warranties, express or implied.
44. ENTIRE AGREEMENT
This document constitutes the entire agreement between the parties and supersedes all prior agreements.
45. GOVERNING LAW
This Agreement shall be governed by and construed under the laws of the State of Florida.
BY NUTRITION LABORATORIES
Date: ______________________________
Signature: ________________________________________________
Print name and title: _______________________________________
BY CUSTOMER: __________________________________________________________________________________________________________________________
(COMPANY NAME AND ADDRESS)
Date: ______________________________
Signature: ________________________________________________
Print name and title: _______________________________________