ORIGINAL ISSUE 1/1/2019, REVISED 1/1/2025, REVISION #2 9/24/2025
MANUFACTURING TERMS & CONDITIONS
GENERAL INFORMATION: Nutrition Laboratories operates a product development laboratory and a beverage bottling plant in Clearwater, Florida, developing and co-packing beverages and liquid dietary supplements (“Products”). This document sets forth the terms, conditions and obligations under which Nutrition Laboratories will produce Products for a Customer.
1. GENERAL TERMS AND CONDITIONS
Nutrition Laboratories will perform its services in accordance with its Current Good Manufacturing Practices. Nutrition Laboratories will charge for its services either as a day fee or a per-bottle co-packing rate produced, or as otherwise agreed with Customer. Nutrition Laboratories shall email Customer a written Proposal for the services to be performed. Customer shall pay a minimum downpayment of 50%, which signifies Customer’s acceptance of the Proposal. The remaining balance is due and payable per said proposal. Nutrition Laboratories shall provide Customer a final invoice at the conclusion of each job.
2. FORMULA OWNERSHIP
Formulations provided by Customer are Customer’s property. Formulations developed by Nutrition Laboratories and paid for by Customer are Customer’s property. Nutrition Laboratories shall keep all such Customer’s formulations confidential. Formulations developed by Nutrition Laboratories and not paid for by Customer are Nutrition Laboratories’ property. Any changes or alterations made to customer-owned formulas by Nutrition Laboratories at Customer’s request shall not grant Nutrition Laboratories any ownership rights of such Customer-owned formulas.
3. PROCESS AUTHORITY AND FDA NOTIFICATION
As applicable, Nutrition Laboratories will obtain a Process Authority letter to produce the Customer’s Products, and file a process notification with the US FDA as required.
4. PROCUREMENT BY CUSTOMER
Unless otherwise agreed to, Customer shall be responsible for purchasing ingredients and components used to produce Products. Customer shall ensure that these conform to specifications set forth in the Product’s master formula and are fit for their intended use. Customer will provide Nutrition Laboratories with Certificates of Analysis and Safety Data Sheets for each ingredient supplied by Customer.
5. PROPRIETARY BLENDS SUPPLIED BY CUSTOMER
If Customer supplies a proprietary blend, Customer affirms that ingredients used in the blend are safe and approved for human consumption. Customer also affirms that the potency of ingredients and such blends are as declared on the Certificate of Analysis and will hold Nutrition Laboratories harmless for any deficiency in such ingredients or blends.
6. DELETED
7. DELETED
8. PRODUCT LABELS
Customer shall provide 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 labels before they are printed, including changes to existing labels. Customer is responsible for regulatory compliance of product labels, including any structure and function claims. Nutrition Laboratories can provide Nutrition Facts and Supplement Facts panels for labels at no charge, and give referrals to label printers.
9. DELETED.
10. ORGANIC CERTIFICATION
If Customer wants a Product certified organic, Nutrition Laboratories will make the organic product calculation, assemble the required documentation and submit to the Company’s organic certifier. The annual charge (due on first certification and each July 1 thereafter) is $650 per product.
11. LABELING WITH ORGANIC INGREDIENTS
Labels for products that are not certified organic but list organic ingredients must be approved by Nutrition Laboratories organic certifier before printing. Nutrition Laboratories’ Quality Director will instruct Customer on the requirements for such approval.
12. PURCHASES BY NUTRITION LABORATORIES
If Customer wants Nutrition Laboratories to purchase components and/or ingredients, Nutrition Laboratories will first submit purchase orders for Customer's approval. Nutrition Laboratories will then place purchase orders for such components and ingredients after receiving payment in full from Customer. Nutrition Laboratories will add a logistics fee to such purchases.
13. CUSTOMER-PROVIDED INGREDIENTS AND COMPONENTS
Ingredients, bottles, caps, labels, case boxes, and other components that Customer provides must arrive at Nutrition Laboratories' warehouse at least ten working days before a scheduled production, unless otherwise agreed to.
14. INGREDIENTS FOR A FIRST PRODUCTION
Ingredients for a first production by Nutrition Laboratories must arrive no less than fifteen working days before scheduled production. This is to give Nutrition Laboratories time to make lab samples to submit to the company’s Process Authority and make a process filing with the FDA.
15. MISSING INGREDIENTS OR COMPONENTS
If Customer-provided ingredients or components have not arrived to Nutrition Laboratories prior to a scheduled production, and if Nutrition Laboratories cannot fill the production slot(s) with another job, Nutrition Laboratories has the option to charge a day fee for each day of cancelled production. If Customer-provided labels have not arrived in time for a scheduled production, Nutrition Laboratories has the option to produce the Products without labels. Final payment will then be due when Products pass microbial test following bottling but without labels. Labeling and pack out will then be scheduled when labels have arrived at such time that Nutrition Laboratories can fit it into its labeling schedule. Nutrition Laboratories has the option to charge Customer for the extra labor necessary to label Products.
16. LEAD TIMES
After acceptance of a Proposal by Customer and downpayment, Nutrition Laboratories and Customer shall agree on a production date. Customer shall ensure that delivery of ingredients and components is made in a timely manner per paragraphs13 or 14 in this agreement.
17. MANUFACTURING
Nutrition Laboratories will manufacture the products using its Current Good Manufacturing Practices, following US FDA and State of Florida regulations, to the specifications set forth in the Products’ Master Manufacturing Record.
17A. MATERIAL WASTE
Customer recognizes that during set up of equipment and in the course of manufacturing, there may be waste of material, including ingredients, bottles, caps and labels.
18. BATCH APPROVAL BY CUSTOMER
Customer or Customer’s representative shall be present on the day of production of Customer’s Product to approve the batch prior to bottling. If Customer decides not to be present, customer authorizes Nutrition Laboratories’ Director of Quality Control to approve the batch on Customer’s behalf. Customer recognizes that Nutrition Laboratories’ Director of Quality Control will use best judgement to do so, and agrees to accept such approval made on Customer’s behalf.
19. QUALITY ASSURANCE
Nutrition Laboratories will monitor the production and packaging of Products in accordance with its quality assurance procedures, detailed in its Current Good Manufacturing Practices manual. A microbial analysis and Certificate of Analysis of each batch is Included in Nutrition Laboratories’ fee.
20. LOT NUMBER AND EXPIRATION DATE
Nutrition Laboratories shall assign to each production batch a lot number and Best-By Expiration Date based on the product’s Process Authority letter and/or stability studies. This information will be printed on each bottle. Alternatively, bottles can be coded with a manufacturing date.
21. PRODUCT HOLD
Nutrition Laboratories will hold the first batch of a new product in quarantine for up to 21 days before releasing for to customer. The purpose of this is to monitor and validate the microbial stability of a product. Subsequent productions of the same product will be quarantined for 48 hours (hot fill) or seven calendar days (cold fill).
22. TRIAL PRODUCTION
Nutrition Laboratories recommends a trial batch production of a new formulation that has not previously been produced commercially and which does not have a proven record of stability of its flavors and functional ingredients.
23. PACK OUT
Products shall be labeled, packed per Customer instructions and placed on pallets. Labor for bulk pack out on pallets is included in Nutrition Laboratories co-packing fee. Labor for packing Products in display boxes, unit boxes or other secondary packaging will be quoted and charged for in addition to the co-packing rate. If Customer wants stickers on trays, master cases or pallets, Nutrition Laboratories can print these based on Customer’s instructions. Customer will be billed for the cost of such packaging material.
24. AMAZON STICKERS
Because products that are to be shipped to Amazon require special pack out, customer must inform Nutrition Laboratories of this prior to palletizing and supply printed stickers for such pack out.
25. PRODUCTION YIELDS
Customer and Nutrition Laboratories acknowledge that in the normal course of production, the number of units of finished goods may be greater or lesser than what is specified in Customer’s purchase order. Customer agrees to accept the finished yield of each production. If Customer is billed at a per-bottle rate rather than a flat fee, Nutrition Laboratories will charge for only the number of bottles produced.
26. DELIVERY
Customer shall take delivery of Products FOB Nutrition Laboratories’ warehouse in Clearwater, Florida. Customer agrees to take delivery products within five business days of written notice from Nutrition Laboratories that the lot(s) are available for pick up, unless otherwise agreed to between the parties. Nutrition Laboratories assumes the cost and risk of loading trucks at its dock. Unless otherwise agreed to, Nutrition Laboratories shall not be required to custom load or arrange loading for more than to one destination.
27. WAREHOUSE STORAGE
Nutrition Laboratories provides free warehouse storage of ingredients and components received four weeks before a scheduled production and of finished products for two weeks following the completion of the job. For repeat customers, Nutrition Laboratories has the option to provide free warehouse storage of ingredients and components providing these are used within three months following the latest production. Nutrition Laboratories does not provide warehouse storage for ingredients and components past three months following the latest production for a repeat customer.
28. DISCARDING OF PRODUCTS, INGREDIENTS, LABELS AND COMPONENTS
Nutrition Laboratories shall have the right to discard Products not claimed by Customer after 90 days following the latest production. Nutrition Laboratories shall have the right to discard ingredients, labels and other components not claimed by Customer after 90 days following the latest production. Customer agrees to pay the cost of such disposal.
29. EXPIRED INGREDIENTS
Nutrition Laboratories will discard Customer ingredients that have passed their expiration dates.
30. PRODUCT LIABILITY INSURANCE
Nutrition Laboratories shall maintain Product liability insurance with an aggregate limit of $2 million.
31. CLAIMS, AND SALE AND DISTRIBUTION
Customer is responsible for any label and advertising claims made for Products, and must make his own due diligence before using any description or information that Nutrition Laboratories may provide about the Products and/or their ingredients on labels or in advertising. Customer is responsible for compliance with all laws or regulations governing the sale or distribution of the Products. Customer will hold Nutrition Laboratories harmless from any liability arising from such claims, sale and distribution.
32. STORAGE AND HANDLING OF PRODUCT BY CUSTOMER
Customer recognizes that the stability of the Products is based on storing them as specified in the Product’s Master Formula and/or Certificate of Analysis. Customer also recognizes that the integrity of the Products’ closure (cap) is essential for the Product’s microbial stability, and that a defective cap, rough handling of or dropping a Product may breach the closure and cause microbial contamination.
33. INSPECTION
Customer has thirty (30) days after receipt of Products to inspect them to determine that they conform to their specifications. 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 Paragraph 36.
34. CONSEQUENTIAL DAMAGES
Except for product liability insurance claims, the liability of Nutrition Laboratories for a confirmed non-conforming or defective product, caused by actions of Nutrition Laboratories, is limited to the replacement of that product to customer. Nutrition Laboratories shall not be responsible for and is relieved by Customer from any claims for consequential damages that result or may result from such non-conforming or defective Product. Nutrition Laboratories is also relieved by Customer from any other consequential damages, including, but not limited to, production delays.
35. CLAIM LIMITATIONS
Unless otherwise specified in this agreement, any claim by either party arising out of or relating to this Agreement must be brought no later than 180 days after the latter of: (i) the date the claim arises, or (ii) the date the claimant first becomes aware of the claim. Claims not brought within the time provided herein shall be barred and discharged.
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
Notwithstanding any other provision contained in this document, if either party is delayed or prevented from performing its obligations under this document by any cause beyond its reasonable control including, but not limited to, acts of God, war, terror, fire, traffic interruptions, severe weather conditions, governmental laws or orders, shortage of materials, equipment failure, strikes or labor disturbances, epidemics or pandemics, that party’s performance shall be suspended or excused without damages, costs or penalties while such cause exists. The party whose performance is affected by the Force Majeure shall use its best efforts to overcome the event.
38. NOT A JOINT VENTURE
Nothing contained in this document shall be interpreted as creating a joint venture or other business association other than the contractual relationship between Nutrition Laboratories and Customer.
39. ABANDONING A PRODUCTION
If Customer abandons a scheduled production, any payment received by Nutrition Laboratories is forfeited.
40. PAYMENT DELAYS
If Customer’s final payment is unduly delayed, future productions for Customer will 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.
45. OBLIGATIONS
Obligations described in this document including in its Exhibits are the only obligations between the parties with respect to the subject matter hereof and supersedes all prior agreements and understandings.
46. GOVERNING LAW
Governing laws for obligations set forth in this document are the laws of the State of Florida.
BY NUTRITION LABORATORIES:
Date: ______________________________
Signature: ________________________________________________
Print name and title: ____________________________________
BY CUSTOMER: ______________________________________________________________________________ (COMPANY NAME)
Date: ______________________________
Signature: ________________________________________________
Print name and title: ____________________________________
