Your Nutraceutical Innovation Partner
Terms and Conditions of Sale
1. Applicability
These Terms and Conditions of Sale (these “Terms”) govern the sale of goods by VIVA Manufacturing, LLC, a Florida corporation (“VIVA”) to the Customer (“Customer”). These Terms apply to any mutually agreed upon, customer-signed Request for Quote and customer-issued purchase order accepted by VIVA (titled together as an “Agreed-Upon Purchase Order”) from the Customer named on such Agreed-Upon Purchase Order. Such Agreed-Upon Purchase Order and these Terms together comprise the entire agreement between Customer and VIVA (the “Contract”), and, unless otherwise agreed in a written document signed by Customer and VIVA, supersede all prior or contemporaneous understandings, agreements, negotiations, representations and warranties, and communications. These Terms prevail over any of Customer’s general terms and conditions of purchase regardless of whether or when Customer has submitted its purchase order or such terms; any such purchase order terms or terms otherwise submitted by Customer (including those attached to the Agreed-Upon Purchase Order or purportedly incorporated therein by reference to an external website hosting such terms and conditions) are hereby rejected by VIVA and shall not become part of the Contract. Fulfillment of Customer’s order does not constitute acceptance of any of Customer’s terms and conditions and does not serve to modify or amend these Terms. In the event of any conflict between an Agreed-Upon Purchase Order and these Terms, these Terms shall control.
2. Manufacture of Goods
(a) VIVA agrees that it will manufacture the nutraceuticals or other products (collectively, the “Goods”) specified on the applicable Agreed-Upon Purchase Order in accordance with written specifications for such Goods provided by Customer in the Agreed-Upon Purchase Order and agreed to in writing by VIVA (the “Specifications”). VIVA agrees, when manufacturing such Goods, to comply with Good Manufacturing Practices (“cGMP”) of the United States Food and Drug Administration (“FDA”) applicable to the Goods. VIVA shall perform such manufacturing at VIVA’s facilities (the “Manufacturing Facility or Facilities”).
(b) Customer represents and warrants that it has all rights and power necessary to authorize VIVA to manufacture the Goods under the Contract.
(c) VIVA will have no obligation to commence manufacture of any Goods unless (i) Customer and VIVA have agreed upon the Specifications and (ii) Customer has made any down payment, deposit, or advance payment specified in Section 12(a) or the applicable Agreed-Upon Purchase Order.
(d) Any completion dates, expected delivery dates, accepted receipt dates, or similar information included in an Agreed-Upon Purchase Order are estimates and shall not be binding on VIVA.
(e) Once the initial manufacturing process is complete, VIVA shall not be required to rework any finished Goods unless otherwise agreed by VIVA and Customer. In such an event, VIVA will advise Customer of the cost of any rework requested by Customer, and VIVA shall not commence any rework unless and until Customer agrees in writing (which may be by email) with such cost. Customer shall pay VIVA the cost of the rework in full upon invoicing, notwithstanding any other payment terms that apply to the original Agreed-Upon Purchase Order.
3. Labeling and Packaging
(a) Customer shall supply to VIVA all artwork (“Artwork”) and Customer-supplied labels and packaging (other than Artwork, “Customer Items”). If Customer does not supply Artwork to VIVA within 3 weeks after the Agreed-Upon Purchase Order is accepted by VIVA and all other Customer Items to VIVA within 8 weeks after the date on which the Agreed-Upon Purchase Order is accepted by VIVA, then VIVA shall be permitted to hold production of the batch until the Artwork and/or Customer Items (as applicable) are approved. This will impact the “due by” date estimated in the Agreed-Upon Purchase Order, which will be communicated in writing to Customer. Please see the section below on Delays for more detail. Once Artwork and Customer Items are received, Finished Good (as defined below) production may begin.
(b) Customer shall be solely responsible for ensuring that all labels, packaging materials and other Customer Items it supplies are fully compliant with applicable laws and regulations including, without limitation, FDA requirements. Any feedback provided by VIVA to Customer regarding labels and packaging including, without limitation, any label review checklist or similar document prepared by VIVA, shall be for Customer’s information only, with no warranty of accuracy or completeness, and shall not give rise to any liability of VIVA. Customer shall have the sole discretion to determine the content of its labels and shall bear all liability for such content. If VIVA determines that any labels, packaging materials or other Customer Items do not comply with applicable law, VIVA may reject non-compliant labels or packaging. If rejected, VIVA reserves the right to assess impact on the delivery schedule and make adjustments as needed. VIVA’s failure to reject labels, Packaging Materials or other Customer Items does not relieve Customer of any of its obligations under this Section to ensure the compliance thereof under applicable law. VIVA will not be liable for any delays, costs, losses, penalties, claims, damages, or other consequences arising from or related to Customer’s non‑compliant labels, Packaging Materials, or other Customer Items.
4. Product Documentation
Following completion of manufacture of the Goods, VIVA will provide Customer with one or more documents evidencing that the Goods were manufactured in accordance with Specifications and cGMP. Such documents may include, without limitation, Certification of Analysis, Master Product Specifications, Composition Analysis, Safety Data Sheet, Letter Guarantee, Certificate of Conformance, or Letter of Origin. If Customer requests such documents before completion of manufacture, VIVA may do so for an additional, nonrefundable documentation fee.
5. Title and Risk of Loss
Notwithstanding anything in the Contract to the contrary, title to and risk of loss of Goods shall pass to Customer immediately upon completion of manufacture, which includes for a full Agreed-Upon Purchase Order or for select batches within that Agreed-Upon Purchase Order, without the requirement of delivery of any specific documentation from VIVA to Customer. VIVA’s internal records regarding the time at which manufacture is completed shall be conclusive evidence of the passage of title. For the avoidance of doubt, when successive batches of Goods are produced (as set forth in the applicable Agreed-Upon Purchase Order), then title will pass on a batch-by-batch basis as evidenced by VIVA’s internal manufacturing records.
6. Storage of Goods Until Shipment
(a) From the time that title to Goods passes to Customer in accordance with Section 5 until the time that Customer’s carrier picks up such Goods at the Manufacturing Facility, VIVA shall store the Goods at the Manufacturing Facility awaiting the arrival of Customer’s carrier. Customer shall bear all risk of loss to the Goods following transfer of title and VIVA shall have no obligation to insure the same (regardless of if VIVA stores the Goods as provided in the Contract). VIVA shall reasonably cooperate with Customer if Customer requests assistance with adding the Goods to Customer’s insurance policies following transfer of title.
(b) If Customer’s carrier has not picked up the Goods from the Manufacturing Facility within 30 days after Customer has received notice from VIVA that manufacture of the Goods is complete, then VIVA may charge Customer a storage fee at VIVA’s then-current rates until the Goods are picked up.
(c) If Customer’s carrier has not picked up the Goods from the Manufacturing Facility within 60 days after Customer has received notice from VIVA that manufacture of the Goods is complete, then VIVA shall give notice of such failure to Customer and Customer shall have 30 days from the date of such notice to cause the Goods to be picked up from the Manufacturing Facility. If Customer does not cause such Goods to be picked up by the end of such 30-day period, VIVA reserves the right to deem the Goods abandoned by Customer. Any Goods deemed abandoned may be, at VIVA’s option, either stored by VIVA for a storage fee or destroyed by VIVA for a destruction fee and without liability to VIVA.
7. Shipping and Delivery
(a) Customer shall be responsible for arranging shipment of the Goods from the Manufacturing Facility to a location designated by Customer. Shipping terms shall be F.O.B. Origin from the Manufacturing Facility unless otherwise agreed in an Agreed-Upon Purchase Order. Customer shall pay all shipping and handling expenses. VIVA shall not be liable for any delays, loss, or damage in transit. Notwithstanding the foregoing, if agreed in writing by Customer and VIVA, VIVA will coordinate shipping of the Goods for a fee.
(b) VIVA will not release the finished Goods for shipment until the Certificate of Analysis and other critical documentation are complete. If Customer would like to ship the Goods before that, VIVA can provide Customer with a Quarantine Letter to sign, signaling receipt before final testing is complete.
8. Non-Receipt
(a) The quantity of Goods as recorded by VIVA on pickup from the Manufacturing Facility is conclusive evidence of the quantity received by Customer on pickup unless Customer can provide conclusive evidence proving the contrary.
(b) VIVA shall not be liable for any non-receipt of Goods unless VIVA has arranged for shipment and Customer gives written notice to VIVA of the non-receipt within 5 days of the date when the Goods would in the ordinary course of events have been received.
(c) Any liability of VIVA for non-receipt of the Goods shall be limited to replacing the Goods within a reasonable time or adjusting the price paid by Customer respecting such Goods to reflect the actual quantity delivered.
(d) Customer acknowledges and agrees that the remedies set forth in Section 8(c) are Customer’s exclusive remedies for non-receipt of Goods.
9. Customer’s Acts or Omissions
If VIVA’s performance of its obligations under the Contract is prevented or delayed by any act or omission of Customer or its agents, subcontractors, consultants or employees, VIVA shall not be deemed in breach of its obligations under the Contract or otherwise liable for any costs, charges or losses sustained or incurred by Customer, in each case, to the extent arising directly or indirectly from such prevention or delay.
10. Inspection and Rejection of Nonconforming Goods
All Goods shall be deemed accepted by Customer unless VIVA delivers Goods that do not conform with the Contract and Customer provides VIVA with written notice specifying such non-conformance within 10 days after VIVA notifies Customer that manufacture of the Goods is complete. If VIVA delivers nonconforming Goods to Customer and Customer notifies VIVA within such 10-day period, Part 6 of Article 2 of the Uniform Commercial Code as adopted in Florida shall govern the rights and obligations of the parties with respect to such nonconforming Goods, subject to any agreement between the parties regarding the return or replacement of such nonconforming Goods. Customer’s sole and exclusive remedy for valid nonconformance claims is limited to replacement of the Goods or a price adjustment, at VIVA’s option.
11. Price
(a) The Purchase Order structure:
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Transactional Purchase Order: A Purchase Order placed for one Production run of one SKU.
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Blanket Agreement: An agreement where Customer and VIVA both agree to 3 to 6 months of Production runs with multiple releases for one SKU. Blanket Agreements are preferred by VIVA because they allow negotiation for better pricing with VIVA’s Suppliers.
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Bundle Purchase Order: One Bundle of POs for multiple SKUs to be produced within an agreed-upon time frame – allowing Customer and VIVA to find mutually beneficial pricing across the Bundle.
(b) Customer shall purchase the Goods from VIVA at the price (the “Price”) set forth on the face of the Agreed-Upon Transactional or Bundle Purchase Order signed by VIVA.
(c) In the case of a Customer-provided Blanket Purchase Order, once accepted by Supplier, pricing will remain firm for the term of the blanket agreement. Any proposed price change to a Blanket Purchase Order, typically caused by market forces changing the pricing, shall be communicated at least thirty (30) days in advance of the production due by date and will be subject to Customer’s written approval.
(d) All prices are stated exclusive of all sales, use, excise, or similar taxes, as well as tariffs, duties, or charges of any kind imposed by any governmental authority on amounts payable by Customer. Customer shall be solely responsible for the payment of all such taxes, tariffs, duties, and charges. Notwithstanding the foregoing, Customer shall not be responsible for any taxes imposed on, or with respect to, VIVA’s income, revenues, gross receipts, personnel, or real or personal property, or other assets.
(e)In addition to the Price, Customer shall pay VIVA all applicable fees for services or other work performed by VIVA pursuant to the fee schedule referenced hereto as Exhibit A and incorporated herein by reference. All such fees shall be due on demand unless otherwise agreed in writing by VIVA.
12. Payment Terms
(a) Unless otherwise set forth in the Agreed-Upon Purchase Order signed by Customer and VIVA, Customer shall pay 50% of the Price of the Goods within 2 business days after VIVA accepts the Purchase Order. Any such payment is non-refundable unless VIVA cancels the applicable Agreed-Upon Purchase Order pursuant to Section 18.
(b) Unless otherwise set forth in the Agreed-Upon Purchase Order and / or agreed by Customer and VIVA in writing, the remaining balance of the Price is due after manufacturing of the Goods is complete. VIVA will send Customer an invoice after completion of manufacture that will specify the due date. If no due date is specified, payment will be due upon delivery of the invoice.
(c) All payments shall be made in US Dollars by ACH transfer. VIVA may accept other payment methods at the request of Customer, provided that Customer pays any reasonable charges assessed by VIVA in connection with VIVA’s acceptance of alternate payment methods.
(d) If Customer fails to make any payments when due, Customer shall pay interest on all past due payments at the lesser of the rate of 1.5% per month or the highest rate permissible under applicable law, calculated daily and compounded monthly. Customer shall reimburse VIVA for all costs incurred in collecting any past due payments, including, without limitation, attorneys’ fees. VIVA may suspend further performance or delivery of any Agreed-Upon Purchase Order until all past due amounts are paid in full to VIVA.
(e) If a Customer payment is returned, dishonored, or otherwise insufficient, Customer shall repay VIVA such amount plus an administrative fee of 10% of the returned amount within 5 days after VIVA notifies Customer that the payment was insufficient.
(f) Customer shall not withhold payment of any amounts due and payable by reason of any set off of any claim or dispute with VIVA, whether relating to VIVA’s breach, bankruptcy, or otherwise.
(g) As collateral security for the payment of the Price, Customer hereby pledges and grants to VIVA a lien on and security interest in and to all of the right, title, and interest of Customer in, to, and under all finished Goods, wherever located, and whether now existing or hereafter arising or acquired from time to time, and in all accessions thereto and replacements or modifications thereof, as well as all proceeds (including insurance proceeds) of the foregoing. The security interest granted under this provision constitutes a purchase money security interest as such term is defined in the Uniform Commercial Code.
13. Compliance with Laws
Each party shall comply with all laws and regulations applicable to its performance of its obligations under the Contract.
14. Non-Exclusive Relationship
VIVA is manufacturing the Goods for Customer on a non-exclusive basis. VIVA reserves the right to manufacture goods that compete with Customer’s Goods for parties other than Customer.
15. Warranties
(a) Customer represents and warrants that it owns all rights and title to any logos, tradenames, trademarks, designs, or other intellectual property included in any labels or packaging and / or to any formulas provided by Customer to VIVA.
(b) VIVA warrants that the Goods will be manufactured in accordance with cGMP and the Specifications. For the avoidance of doubt, VIVA is not responsible for natural variances in the color of Goods due to the use of natural ingredients.
(c) TO THE FULLEST EXTENT PERMITTED BY LAW, ALL OTHER WARRANTIES ARE DISCLAIMED AND WAIVED, INCLUDING ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. CUSTOMER IS SOLELY RESPONSIBLE FOR DETERMINING THE REGULATORY STATUS OF THE GOODS, INCLUDING COMPLIANCE WITH ALL APPLICABLE LAWS REGARDING LABELING, MARKETING, AND HEALTH CLAIMS. VIVA MAKES NO REPRESENTATION OR WARRANTY, EXPRESS OR IMPLIED, REGARDING THE THERAPEUTIC EFFECT, EFFICACY, OR REGULATORY STATUS OF THE GOODS.
16. Indemnification
(a) Customer shall defend, indemnify and hold harmless VIVA against any and all loss, injury, death, damage, liability, claim, deficiency, action, judgment, interest, award, penalty, fine, cost or expense, including reasonable attorney and professional fees and costs, and the cost of enforcing any right to indemnification hereunder and the cost of pursuing any insurance providers (collectively, “Losses”) arising out of or occurring in connection with (i) all labels, packaging and Customer Items supplied by Customer to VIVA, including, without limitation, of any labels do not comply with any applicable laws or regulations or the requirements of the FDA, (ii) the design, Specifications, marketing, or instructions for use of the Goods, (iii) Customer’s failure to comply with applicable laws, including (without limitation) intellectual property rights, advertising rules and claim substantiation requirements, in connection with the Goods, (iv) any adverse events, product liability claims, or regulatory actions relating to the Goods except to the extent caused by VIVA’s failure to manufacture in material accordance with the Specifications; or (ii) Customer’s negligence, intentional omission, willful misconduct, or breach of the Contract.
(b) VIVA shall defend, indemnify, and hold harmless Customer against any and all losses arising out of or occurring in connection with (i) VIVA’s failure to materially comply with cGMP or Specifications when manufacturing the Goods, or (ii) VIVA’s gross negligence willful misconduct, or breach of the Contract, in each case except to the extent of Customer’s negligence, willful misconduct, or breach of the Contract.
17. Limitation of Liability
(a) IN NO EVENT SHALL EITHER CUSTOMER OR VIVA, OR THEIR RESPECTIVE AFFILIATES OR THEIR RESPECTIVE EMPLOYEES, AGENTS, OR REPRESENTATIVES, BE LIABLE FOR ANY CONSEQUENTIAL, INDIRECT, INCIDENTAL, SPECIAL, EXEMPLARY, OR PUNITIVE DAMAGES, LOST PROFITS OR REVENUES, OR DIMINUTION IN VALUE, ARISING OUT OF OR RELATING TO ANY BREACH OF THESE TERMS, REGARDLESS OF: (1) WHETHER SUCH DAMAGES WERE FORESEEABLE; (2) WHETHER OR NOT THE APPLICABLE PARTY WAS ADVISED OF THE POSSIBILITY OF SUCH DAMAGES; AND (3) THE LEGAL OR EQUITABLE THEORY (CONTRACT, TORT, OR OTHERWISE) UPON WHICH THE CLAIM IS BASED, AND NOTWITHSTANDING THE FAILURE OF ANY AGREED OR OTHER REMEDY OF ITS ESSENTIAL PURPOSE.
(b) IN NO EVENT SHALL VIVA’S AGGREGATE LIABILITY TO CUSTOMER ARISING OUT OF OR RELATED TO THE CONTRACT OR ANY AGREED-UPON PURCHASE ORDER, WHETHER ARISING OUT OF OR RELATED TO BREACH OF CONTRACT, TORT (INCLUDING NEGLIGENCE), RECALL, OR OTHERWISE, EXCEED THE TOTAL AMOUNTS ACTUALLY PAID TO VIVA FOR THE SPECIFIC GOODS GIVING RISE TO THE CLAIM.
(c) WITHOUT LIMITING THE GENERALITY OF THE FOREGOING, CUSTOMER ASSUMES ALL RISK AND LIABILITY FOR THE RESULTS OBTAINED BY THE USE OF ANY GOODS IN THE PRACTICE OF ANY PROCESS, WHETHER IN TERMS OF GENERAL EFFECTIVENESS, SUCCESS OR FAILURE, AND REGARDLESS OF ANY ORAL OR WRITTEN STATEMENTS MADE BY VIVA, BY WAY OF TECHNICAL ADVICE OR OTHERWISE, RELATED TO THE USE OF THE GOODS.
18. VIVA Cancellation of an Agreed-Upon Purchase Order
VIVA may cancel any specific Agreed-Upon Purchase Order at any time prior to commencement of manufacture of the applicable Goods without penalty by providing written notice of cancellation to Customer. If there has been an increase in material cost to VIVA to manufacture the Goods in accordance with the applicable Agreed-Upon Purchase Order occurring after acceptance of an Agreed-Upon Purchase Order, but before commencement of manufacture, VIVA may provide Customer with updated pricing, and if Customer accepts, VIVA will proceed with production. If VIVA cancels an Agreed-Upon Purchase Order prior to ordering materials and Customer has paid a deposit, deposit will be returned by VIVA to Customer.
19. Customer Requests to Cancel an Open Agreed-Upon Purchase Order
(a) If no materials have been procured, the order may be cancelled without penalty.
(b) If materials have been procured but production has not commenced, Customer shall pay a cancellation fee equal to 50% of the order amount, net 10 days. VIVA may utilize or dispose of the acquired materials at its sole discretion.
(c) If materials have been procured and production has commenced but not been completed, the Customer shall pay 80% of the order amount, net 10 days, and VIVA will issue a written cancellation order invoice to Customer upon acceptance. VIVA may utilize or dispose of the acquired materials and the partially completed production at its sole discretion.
(d) If production has been completed, Customer shall remain obligated to pay 100% of the order amount in accordance with the agreed payment terms.
20. Customer Request to Delay the Production Completion or Customer-Caused Production Delays
(a) Customer may issue a delay request prior to material procurement after an Agreed-Upon Purchase Order, and any applicable deposit has been paid, but materials and components have not yet been ordered. Such a delay shall be subject to VIVA’s approval and dependent on the current production capacity and schedule load. Upon reaching an agreed reschedule date, the order may be subject to re-costing, and a revised Request for Quote shall be issued by VIVA and signed by Customer, prior to commencement.
(b) If Customer issues a delay request or customer-supplied materials and/or artwork are delayed after an Agreed-Upon Purchase Order has been received, any applicable deposit has been paid, and materials and components have been ordered by VIVA, Customer may request a delay of up to 30 days beyond the original agreed target production completion date. In such case:
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If a 50% deposit has not yet been paid, Customer must pay such a deposit within 10 business days.
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VIVA may charge storage and insurance fees for the prolonged storage of procured materials.
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Customer will also pay a 10% Production Rescheduling Fee on top of the Agreed-Upon Purchase Order amount
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If Customer is not prepared to proceed after the 30-day extension, all deposit funds paid shall be forfeited, and VIVA may cancel the Agreed-Upon Purchase Order or agree at its options to extend to a mutually agreed upon date, to be determined. VIVA shall have the right to utilize or dispose of the acquired materials at its sole discretion.
(c) If Customer issues a customer delay request after commencement of manufacturing, no request to delay or halt work in progress will be accepted. Customer shall remain fully obligated to complete the manufacturing process of the order and to pay all invoices within the agreed terms of payment.
21. Testing & Analysis
(a) VIVA manufactures, packages, labels, and/or holds dietary supplements in accordance with applicable dietary supplement cGMPs under 21 CFR Part 111, and therefore maintains the required quality system, specifications, quarantine/release controls, label control, batch record documentation, reserve sample retention, and final Quality Control (QC) release for distribution; no batch or packaged/labeled lot will ship without QC approval. QC release and approval will be based on approved Specifications, not on fitness for Customer’s intended claims, testing, or market (for which VIVA bears no liability).
(b) Customer remains responsible for providing complete product requirements and final, approved label artwork/claims (including any “best by/use by” or expiration dating decisions) and for requesting/funding any stability studies or special verification beyond standard cGMP controls. Customer is solely responsible for ensuring that all label content and claims comply with applicable laws and regulations, and VIVA does not evaluate, independently verify, endorse, take responsibility for, or otherwise substantiate marketing claims or other statements, either express or implied, made on packaged product or other media. VIVA reserves the right to reject any proposed label artwork that would place the manufacturer at risk of misbranding or violating federal regulations.
(c) VIVA may place materials or finished Goods on hold and reject components/packaging/labels or lots that cannot be adequately verified or do not meet Specifications, and will retain required records and reserve samples for the applicable retention period while providing reasonable access to Customer of relevant records upon written request for quality or regulatory purposes, subject to confidentiality and administrative requirements.
(d) Additional testing outside of the scope of the requirements outlined under 21 CFR Part 111 is to be requested by Customer as needed, or prior to submitting a customer purchase order, Customer will be invoiced for the additional testing.
22. Stability Testing and Shelf-Life Responsibility
(a) It is the responsibility of Customer, as the brand owner and distributor, to request or facilitate stability testing for Finished Goods to verify shelf-life. VIVA maintains a stability program in accordance with applicable guidelines (21 CFR 211.166, CHPA Stability Guidelines, NSF/ANSI 455-2, and internal SOP 2019). However, VIVA is not responsible for establishing or maintaining a stability program for Customer’s Goods unless such testing is explicitly requested by Customer in writing at the time of customer purchase order placement and accepted by VIVA in writing in advance. If no stability testing is requested or contracted for, VIVA shall not be held liable for claims related to Goods’ shelf-life, expiration dating (i.e., Best By Date, Expiration Date, or Use By Date), or stability performance.
(b) Customer is responsible for establishing and supporting the stability, shelf life, expiration date, or “best by” date of any Finished Good, unless stability testing or shelf-life determination services are expressly included in a separate written agreement with VIVA. In the absence of such an agreement, VIVA does not independently conduct stability studies or make shelf-life determinations and shall not be responsible for the accuracy or substantiation of any expiration or “best by” dating applied to the Goods and VIVA’s manufacture, quality control release, or shipment of the Goods shall not be construed as approval, validation, or substantiation of any shelf‑life, expiration date, or “best by” dating.
(c) If stability testing or shelf-life determination is requested by Customer and agreed to by VIVA in writing, such services will be performed according to the defined scope of work and applicable fees and costs without any warranty or guarantee regarding performance beyond the agreed testing parameters. Responsibility for labeling claims related to Goods dating remains with Customer unless otherwise expressly stated in a signed agreement.
(d) Any change in formulation, manufacturing process, packaging, storage conditions, or component suppliers shall invalidate prior stability data unless otherwise agreed in writing. Furthermore, VIVA shall have no responsibility for product stability affected by Customer’s or third parties’ storage, handling, transportation, or distribution conditions.
23. Master Formulas / Quantitative Formulations
(a) The quantitative formulation and master formula used in the manufacturing of any Goods (the “Master Formula”) are the exclusive intellectual property of VIVA and shall be treated as confidential trade secrets. Customer has rights only to the publicly disclosed label formula as it appears on the Supplement Facts or Nutrition Facts panel and does not have access to the full quantitative or procedural details used in the internal Master Formula. No license, ownership interest, or other rights in or to VIVA’s quantitative formulation, Master Formula, manufacturing processes, or related know‑how are granted to Customer, whether by implication, estoppel, or otherwise. Customer shall not attempt to derive, analyze, reverse engineer, or recreate VIVA’s quantitative formulation or manufacturing processes for the Goods, documentation, or any information made available under the Contract.
(b) VIVA shall prepare a Master Manufacturing Record (MMR) for each formula and batch size in accordance with 21 CFR Part 111 Subpart H. Each MMR is based on VIVA’s proprietary processes and formulation specifications and shall remain the sole property of VIVA. Ownership of the MMRs shall survive expiration or termination of the Contract. Customer shall have no right to copy, transfer, disclose, or use the MMRs, or to permit their use, for manufacture by any third party.
(c) VIVA shall retain all records referenced in this section for the required regulatory timeframes and make them available to Customer QA upon reasonable request, solely for the purposes of verifying compliance and Goods quality. Access shall not extend to proprietary formulation content or trade secret information unless otherwise agreed in writing. Nothing in the Contract shall restrict VIVA from disclosing records to regulatory authorities as required by applicable law.
24. New Dietary Ingredient (NDI) Responsibility
(a) Customer acknowledges that, as the brand owner and distributor of the Finished Goods, Customer is responsible for compliance with applicable requirements related to New Dietary Ingredients (“NDIs”) under Section 413 of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. §190.6. This includes determining whether any dietary ingredient or Finished Good requires an NDI notification and, if applicable, ensuring that such notification is submitted to the FDA. Customer represents and warrants that it has evaluated the NDI status of all dietary ingredients supplied to or specified for use by VIVA and has complied, or will comply, with all applicable NDI notification requirements
(b) VIVA operates as a contract manufacturer and does not independently assess whether a Good or ingredient requires an NDI notification. Responsibility for regulatory determinations related to NDIs remains with Customer. VIVA has no obligation to independently evaluate, monitor, or advise on the NDI status of any ingredient and shall have no duty to warn Customer of potential NDI issues.
(c) At Customer’s request, VIVA may provide reasonable technical or documentary support to assist Customer with regulatory evaluations. Any such support will be provided on an as-needed basis and billed at VIVA’s then-current hourly consulting rates. Provision of support does not constitute a determination or certification of NDI compliance by VIVA and any support provided by VIVA shall be based solely on information supplied by Customer or its ingredient vendors, and Customer remains solely responsible for all regulatory conclusions and submissions. Customer shall not rely on such support as legal or regulatory advice.
(d) Customer agrees to indemnify and hold VIVA harmless from regulatory actions, claims or enforcement actions and related costs, losses and penalties arising from Customer’s failure to meet NDI-related obligations including, without limitation, failure to determine or comply with NDI notification requirements and the inclusion of any ingredient that constitutes an NDI without a required and effective notification.
25. Labeling, Claims, Advertising, and Regulatory Responsibility
(a) VIVA acts as a contract manufacturer. VIVA’s primary responsibility is to manufacture Goods in accordance with agreed Specifications and cGMP requirements. VIVA is responsible for quality control, proper labeling application, and ensuring Goods are not released in violation of applicable manufacturing regulations.
Customer, as the brand owner and distributor, is responsible for all Goods positioning, claims, marketing language, advertising content, and regulatory compliance related to how the Good is represented in the marketplace. This includes compliance with FDA labeling rules, Federal Trade Commission (“FTC”) advertising standards, and the policies of third-party sales platforms such as Amazon and TikTok.
While VIVA may provide feedback or general guidance regarding labeling or claims, final decisions regarding formula positioning, claim selection, substantiation, marketing content, and international regulatory compliance remain solely with Customer. Customer acknowledges that any such feedback is provided without independent investigation and does not create any duty on the part of VIVA to identify or prevent regulatory or advertising violations. Customer retains responsibility for ensuring that all claims are properly substantiated and compliant with applicable laws in every market where the Goods are sold.
(b) Customer Responsibility for Claims and Marketing
Customer shall be solely responsible for all product claims, marketing representations, advertising content, and promotional materials related to the Goods, whether appearing on product labels, packaging, websites, social media, digital marketplaces (including but not limited to Amazon and TikTok), or other advertising channels.
Customer acknowledges that under the Federal Food, Drug, and Cosmetic Act (“FD&C Act”), including but not limited to 21 U.S.C. §§ 331 and 343, a Good is deemed misbranded if its labeling is false or misleading or otherwise fails to comply with applicable requirements. Customer further acknowledges that dietary supplement claims are governed by 21 U.S.C. § 343(r)(6) and applicable FDA regulations, including 21 CFR Part 101 and 21 CFR § 101.36.
Customer represents and warrants that it possesses competent and reliable scientific evidence sufficient to substantiate all express and implied claims in accordance with applicable law, including but not limited to the FD&C Act and the Federal Trade Commission Act (“FTC Act”), 15 U.S.C. §§ 45 and 52. Customer acknowledges that VIVA does not independently verify claim substantiation and that VIVA’s manufacture, quality control release, or labeling application does not constitute approval or validation of any claim.
(c) VIVA Role; No Legal or Advertising Advisory Services
VIVA acts solely as a contract manufacturer. Any comments, feedback, suggested edits, or observations provided by VIVA regarding labeling, structure/function claims, advertising language, or regulatory considerations are informational only and shall not constitute legal advice, regulatory certification, advertising approval, or claim substantiation review.
Customer acknowledges that VIVA does not provide legal services or advertising substantiation review under the FTC Act (15 U.S.C. §§ 45 and 52), nor does VIVA certify compliance with FDA labeling regulations under 21 CFR Part 101, unless expressly agreed to in a separately executed written agreement.
(d) FDA cGMP and Label Control Responsibilities
VIVA shall perform its manufacturing, packaging, labeling, and release obligations in accordance with applicable dietary supplement cGMP regulations set forth in 21 CFR Part 111, including but not limited to label control, examination, review, and approval requirements under 21 CFR §§ 111.70, 111.127, 111.155, 111.410–111.460.
VIVA reserves the right to reject labeling that is clearly non-compliant with applicable FDA regulations or that would render the Goods misbranded under 21 U.S.C. § 343.
Nothing herein shall be construed to shift VIVA’s independent regulatory obligations under 21 CFR Part 111; however, compliance review conducted by VIVA pursuant to cGMP requirements does not relieve Customer of its sole responsibility for claims, marketing representations, or advertising compliance and VIVA’s review of labeling pursuant to cGMP requirements is limited to manufacturing compliance and does not include a comprehensive review of marketing claims or advertising substantiation.
(e) Platform Compliance
Customer shall be solely responsible for compliance with the policies, standards, and requirements of any third-party sales or marketing platforms, including but not limited to Amazon, TikTok, Meta, Google, or other marketplaces. VIVA makes no representations or warranties regarding platform approval, listing eligibility, content moderation decisions, or marketplace enforcement actions.
(f) International Regulatory Compliance
Unless expressly agreed to in writing, VIVA provides Goods solely for compliance with applicable United States laws and regulations. Customer is solely responsible for compliance with all international laws, regulations, labeling requirements, manufacturing standards, import/export controls, Goods registrations, and market-specific claim restrictions outside the United States.
(g) Formula Development and Allocation of Responsibility
The parties acknowledge that product formulas may originate under one of several models, including:
(i) formula provided by Customer;
(ii) formula provided by Customer with manufacturing recommendations by VIVA;
(iii) jointly developed formula; or
(iv) formula developed by VIVA and presented to Customer.
In all cases, Customer retains sole responsibility for final claim selection, marketing positioning, advertising content, and substantiation of any claims made regarding the Goods under 21 U.S.C. § 343(r)(6), 21 CFR Part 101, and the FTC Act and no formula development model shall alter the allocation of regulatory, claims, or advertising responsibility set forth in this Section.
(h) Indemnification for Claims and Advertising
Customer shall defend, indemnify, and hold harmless VIVA from and against any and all claims, investigations, enforcement actions, liabilities, damages, penalties, costs, or expenses arising out of or relating to:
(i) product claims or advertising representations;
(ii) alleged lack of substantiation under the FTC Act (15 U.S.C. §§ 45, 52);
(iii) alleged misbranding under 21 U.S.C. §§ 331 or 343;
(iv) regulatory enforcement by the U.S. Food and Drug Administration or Federal Trade Commission;
(v) platform suspension or listing removal; or
(vi) international regulatory non-compliance,
except to the extent directly caused by VIVA’s failure to manufacture the Goods in accordance with mutually agreed Specifications and applicable cGMP requirements under 21 CFR Part 111. This indemnification obligation shall survive expiration or termination of the Contract.
26. Adverse Events
(a) Customer, as the brand owner and distributor of the Goods, is solely responsible for receiving, monitoring, evaluating, investigating, documenting, and reporting all Adverse Events and Serious Adverse Events (each as defined in Section 761 of the FD&C Act and applicable FDA guidance) associated with the Goods, including submitting any required reports to the FDA in accordance with applicable law.
(b) VIVA acts solely as a contract manufacturer and does not independently monitor consumer complaints or adverse events in the marketplace. VIVA has no obligation to evaluate, investigate, or determine the reportability of any Adverse Event or Serious Adverse Event.
If VIVA receives information that reasonably appears to involve a Serious Adverse Event relating to the Goods, VIVA shall promptly forward such information to Customer.
(c) At Customer’s reasonable request, VIVA may provide manufacturing or technical information within its possession that is reasonably necessary to support Customer’s investigation or regulatory reporting.
(d) Any information or assistance provided by VIVA is informational only and does not constitute legal advice, regulatory certification, or approval of the Goods.
(e) Customer shall defend, indemnify, and hold harmless VIVA from and against any claims, investigations, enforcement actions, liabilities, damages, penalties, or expenses arising out of or relating to Customer’s adverse event reporting obligations, except to the extent directly and solely caused by VIVA’s failure to manufacture the Goods in accordance with applicable dietary supplement cGMP requirements under 21 CFR Part 111.
27. Remedy for Breach
In addition to any other rights or remedies available to VIVA at law or in equity, if Customer breaches the Contract, VIVA may (a) cancel any open orders and return to Customer any amounts received by Customer for Goods not manufactured, less a reasonable administrative charge, or (b)refuse to deliver any Goods that Customer has ordered but that have not yet been shipped to Customer (in which case VIVA shall return to Customer any amounts paid by Customer for Goods not shipped by VIVA, less a reasonable administrative charge).
28. Waiver
No waiver by VIVA of any of the provisions of the Contract is effective unless explicitly set forth in writing and signed by VIVA. No failure to exercise, or delay in exercising, any right, remedy, power, or privilege arising from the Contract operates, or may be construed, as a waiver thereof. No single or partial exercise of any right, remedy, power, or privilege hereunder precludes any other or further exercise thereof or the exercise of any other right, remedy, power, or privilege.
29. Force Majeure
VIVA shall not be liable or responsible to Customer, nor be deemed to have defaulted or breached the Contract, for any failure or delay in fulfilling or performing any term of the Contract when and to the extent such failure or delay is caused by or results from acts or circumstances beyond the reasonable control of VIVA including, without limitation, acts of God, flood, fire, earthquake, explosion, governmental actions, war, invasion or hostilities (whether war is declared or not), terrorist threats or acts, riot, or other civil unrest, national emergency, revolution, insurrection, epidemic, lockouts, strikes or other labor disputes, or restraints or delays affecting carriers or inability or delay in obtaining supplies of adequate or suitable materials, materials or telecommunication breakdown or power outage, provided that, if the event in question continues for a continuous period in excess of 90 days, Customer shall be entitled to terminate the Contract by providing written notice of termination to VIVA.
30. Assignment
Customer shall not assign any of its rights or delegate any of its obligations under the Contract without the prior written consent of VIVA which shall not be unreasonably delayed or denied. Any purported assignment or delegation in violation of this Section is null and void. No assignment or delegation relieves Customer of any of its obligations under the Contract.
31. No Third-Party Beneficiaries
The Contract is for the sole benefit of the parties hereto and their respective successors and permitted assigns, and nothing herein, express or implied, is intended to or shall confer upon any other person or entity any legal or equitable right, benefit or remedy of any nature whatsoever under or by reason of the Contract.
32. Governing Law; Venue
This Agreement shall be governed by and construed in accordance with the laws of the State of Florida, USA. If, and solely to the extent that, any dispute or claim arising out of or relating to this Agreement cannot be submitted to arbitration under Section 20 because applicable law prohibits arbitration of such dispute or claim, the parties agree that such dispute or claim shall be brought exclusively in the state or federal courts with jurisdiction over Tampa, Florida, and each party irrevocably submits to the personal jurisdiction of those courts for that limited purpose.
33. Arbitration
(a) Any controversy or claim arising out of or relating to this Agreement, or the breach thereof, shall be determined by final and binding arbitration administered by the American Arbitration Association (“AAA”) under its Commercial Arbitration Rules and Mediation Procedures (“Commercial Rules”) including, if appropriate, the Procedures for Large, Complex Commercial Disputes.
(b) The award rendered by the arbitrator shall be final, non-reviewable, and non-appealable and binding on the parties and may be entered and enforced in any court having jurisdiction, and any court where a party or its assets is located.
(c) There shall be one arbitrator agreed to by the parties within twenty (20) days of receipt by respondent[s] of the request for arbitration or in default thereof appointed by the AAA in accordance with its Commercial Rules.
(d) The seat or place of arbitration shall be Tampa, Florida. The arbitration shall be conducted and the award shall be rendered in the English language.
(e) Except as may be required by law, neither a party nor the arbitrator may disclose the existence, content or results of any arbitration without the prior written consent of both parties, unless to protect or pursue a legal right.
(f) The arbitrator will have no authority to award punitive damages, consequential damages, liquidated damages or compensatory damages exceeding the limits set forth in this Contract.
34. Notices
All notices, requests, consents, claims, demands, waivers, and other communications hereunder (each, a “Notice”) shall be in writing and addressed to the parties at the addresses set forth on the face of the Agreed-Upon Purchase Order or to such other address that may be designated by the receiving party in writing. All Notices shall be delivered by personal delivery, nationally recognized overnight courier (with all fees prepaid), email (with confirmation of receipt), or certified or registered mail (in each case, return receipt requested, postage prepaid). Except as otherwise provided in the Contract, a Notice is effective only (a) upon receipt of the receiving party, and (b) if the party giving the Notice has complied with the requirements of this Section.
35. Severability
If any term or provision of the Contract is invalid, illegal, or unenforceable in any jurisdiction, such invalidity, illegality, or unenforceability shall not affect any other term or provision of the Contract or invalidate or render unenforceable such term or provision in any other jurisdiction.
36. Survival
Provisions of the Contract which by their nature should survive will remain in force after any termination or expiration of the Contract, including, but not limited to, the following provisions: Limitation of Liability, Governing Law, Submission to Jurisdiction, and Survival.
37. Amendment and Modification
Except as provided in the Section below, the Contract may only be amended or modified in writing stating specifically that it amends the Contract and is signed by an authorized representative of each party.
38. Revisions
VIVA reserves the right to revise, amend, or update these Terms & Conditions at its discretion. All modifications become effective upon publication at the link previously provided, and Customer's continued engagement with VIVA's services signifies acceptance of the revised terms.
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Exhibit A: Fee Schedule
Provided upon request by Customer’s account manager.
